A simple, sensitive, robust, precise, and efficient RP HPLC approach for the simultaneous determination of Dapagliflozin and Pioglitazone Hydrochloride in Synthetic Mixture. As per ICH Q2 R1 guidelines, the final chromatographic conditions were Optimized with a mobile phase ratio of 25 75 v v in ACN Potassium Dihydrogen Phosphate Buffer pH 4 was adjusted by adding OPA at a flow rate of 1 mL min, column temperature of 30 °C, injection volume of 20 µL, Kromstar Vertex C18 analytical column, and UV detection at 228 nm wavelength. Dapagliflozin and Pioglitazone Hydrochloride reported retention times of 3 min and 6.5 min, respectively. Validation of a method was found to be linear in the range of 2 10 µg ml for Dapagliflozin and 3–15 µg mL for Pioglitazone Hydrochloride. The Recovery for Dapagliflozin was discovered to be 98.52 99.90 , while for Pioglitazone Hydrochloride, it was found to be 99.67 99.94 . The Precision results for both drugs were within the limits while expressed Intraday and Interday. For Dapagliflozin, the LOD and LOQ were reported to be 0.041 µg mL and 0.13 µg mL, respectively, and for Pioglitazone Hydrochloride, 0.105 µg mL and 0.32 µg mL. As per ICH Q1A R2 guidelines, the synthetic mixture was subjected to acid, base, oxidation, thermal, and photolysis stress conditions. Mr. Tarang Patel | Ronak Parikh "Method Development, Validation and Forced Degradation Studies of Dapagliflozin and Pioglitazone Hydrochlorides in Synthetic Mixtures by RP-HPLC" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-6 , October 2022, URL: https://www.ijtsrd.com/papers/ijtsrd52165.pdf Paper URL: https://www.ijtsrd.com/pharmacy/analytical-chemistry/52165/method-development-validation-and-forced-degradation-studies-of-dapagliflozin-and-pioglitazone-hydrochlorides-in-synthetic-mixtures-by-rphplc/mr-tarang-patel
Method Development and Validation for Estimation of Oral Hypoglycaemic Drug D...ijtsrd
HPLC is a chromatographic technique employed in active compound chemistry and biochemistry to separate a mixture and substances with the goal of identifying, measuring, and purifying the different components of the mixture. Its a much better variety of column and traditional chromatography. The objective of the research work is to develop and validate a simple and accurate reverse phase chromatographic method to estimate amount of drug in dosage form. The developed method successfully can be applied to estimate the amount of Dapagliflozin in tablet dosage form. After oral administration of dapagliflozin, the maximum plasma concentration Concentration max under two hours. High performance liquid chromatographic system was alleviated according to the chromatographic settings. After attaining the steady base line, to verify the system suitability, a single 40 µg ml of standard solution proportional to 100 test concentration of dapagliflozin was injected into the HPLC system. The gradient mobile phase flow rate programming assisted in optimising the lengthy run duration and resolution of sample analysis, making the approach more cost effective and quick. Validation of the developed and optimized HPLC method was carried out according to ICH guidelines with respect to parameters such as linearity, specificity, precision and accuracy. Junaid Ahmed | Himanchal Sharma | Shiva Teotia "Method Development and Validation for Estimation of Oral Hypoglycaemic Drug Dapagliflozinina Tablet Dosage form by the Employment of Rp-HPLC" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-6 , October 2021, URL: https://www.ijtsrd.com/papers/ijtsrd46395.pdf Paper URL : https://www.ijtsrd.com/pharmacy/analytical-chemistry/46395/method-development-and-validation-for-estimation-of-oral-hypoglycaemic-drug-dapagliflozinina-tablet-dosage-form-by-the-employment-of-rphplc/junaid-ahmed
Analytical Method Development and Validation of Prednisolone Sodium Phosphate...iosrjce
IOSR Journal of Pharmacy and Biological Sciences(IOSR-JPBS) is a double blind peer reviewed International Journal that provides rapid publication (within a month) of articles in all areas of Pharmacy and Biological Science. The journal welcomes publications of high quality papers on theoretical developments and practical applications in Pharmacy and Biological Science. Original research papers, state-of-the-art reviews, and high quality technical notes are invited for publications.
Stability indicating RP-HPLC method for estimation of dapagliflozin in bulk a...SriramNagarajan19
A simple, specific, accurate, precise and stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method is developed for estimation of Dapagliflozin (DGF) in bulk and Pharmaceutical dosage form. The method employed, Hypersil BDS C18 250 mm x 4.6 mm, 5 mm column in isocratic mode with mobile phase of 0.1% Ortho phosphoric acid buffer and acetonitrile 50:50% v/v. The flow rate was 1.0 mL min-1 and effluent was monitored at 245 nm using PDA detector. The injection volume was 10 µl and the total runtime was set as 5min. The retention time for DGF was found to be 2.226min.The method was validated in terms of Linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ) etc. in accordance with ICH guidelines. Linear regression analysis data for the calibration plot showed that there was a good linear relationship between response and concentration in the range of 25 - 150 µg/ml respectively. The LOD and LOQ values for HPLC method were found to be 0.04 and 0.121 µg/ml respectively. No chromatographic interference from the tablet excipients was found. The proposed method was successfully used for estimation of Dapagliflozin (DGF) in Bulk and Pharmaceutical dosage form.
Method Development and Validation of Clopidogrel Bisulphate by Reverse Phase-...SriramNagarajan15
A new, simple sensitive, rapid, accurate and precise RP-HPLC method was developed for the estimation of Clopidogrel bisulphate in bulk drug and pharmaceutical formulation. Clopidogrel bisulphate was chromatographed on a reverse phase C18column (150 mm x 4.5 mm, i.d 5μm) in a mobile phase consisting of acetonitrile and phosphate buffer (pH: 3.0) in the ratio of 60:40 % v/v. The mobile phase was pumped at a flow rate of 1 ml/min with detection at 224 nm. The detector response was linear in the concentration of 50-150 μg /ml. The limit of detection and limit of quantitation was found to be 1.3 and 4.2 µg/ml, respectively. The intra and inter day variation was found to be less than 2%. The mean recovery of the drug from the solution was 99.79%. The proposed method is simple, fast, accurate, precise and reproducible hence, it can be applied for routine quality control analysis of Clopidogrel bisulphate in bulk drug and pharmaceutical formulation. Key words: Clopidogrel bisulphate, RP-HPLC, Validation, Accuracy, Precision.
Method Development and Validation of Clopidogrel Bisulphate by Reverse Phase-...SriramNagarajan15
A new, simple sensitive, rapid, accurate and precise RP-HPLC method was developed for the estimation of Clopidogrel bisulphate in bulk drug and pharmaceutical formulation. Clopidogrel bisulphate was chromatographed on a reverse phase C18column (150 mm x 4.5 mm, i.d 5μm) in a mobile phase consisting of acetonitrile and phosphate buffer (pH: 3.0) in the ratio of 60:40 % v/v. The mobile phase was pumped at a flow rate of 1 ml/min with detection at 224 nm. The detector response was linear in the concentration of 50-150 μg /ml. The limit of detection and limit of quantitation was found to be 1.3 and 4.2 µg/ml, respectively. The intra and inter day variation was found to be less than 2%. The mean recovery of the drug from the solution was 99.79%. The proposed method is simple, fast, accurate, precise and reproducible hence, it can be applied for routine quality control analysis of Clopidogrel bisulphate in bulk drug and pharmaceutical formulation. Key words: Clopidogrel bisulphate, RP-HPLC, Validation, Accuracy, Precision.
Method Development and Validation for Estimation of Oral Hypoglycaemic Drug D...ijtsrd
HPLC is a chromatographic technique employed in active compound chemistry and biochemistry to separate a mixture and substances with the goal of identifying, measuring, and purifying the different components of the mixture. Its a much better variety of column and traditional chromatography. The objective of the research work is to develop and validate a simple and accurate reverse phase chromatographic method to estimate amount of drug in dosage form. The developed method successfully can be applied to estimate the amount of Dapagliflozin in tablet dosage form. After oral administration of dapagliflozin, the maximum plasma concentration Concentration max under two hours. High performance liquid chromatographic system was alleviated according to the chromatographic settings. After attaining the steady base line, to verify the system suitability, a single 40 µg ml of standard solution proportional to 100 test concentration of dapagliflozin was injected into the HPLC system. The gradient mobile phase flow rate programming assisted in optimising the lengthy run duration and resolution of sample analysis, making the approach more cost effective and quick. Validation of the developed and optimized HPLC method was carried out according to ICH guidelines with respect to parameters such as linearity, specificity, precision and accuracy. Junaid Ahmed | Himanchal Sharma | Shiva Teotia "Method Development and Validation for Estimation of Oral Hypoglycaemic Drug Dapagliflozinina Tablet Dosage form by the Employment of Rp-HPLC" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-6 , October 2021, URL: https://www.ijtsrd.com/papers/ijtsrd46395.pdf Paper URL : https://www.ijtsrd.com/pharmacy/analytical-chemistry/46395/method-development-and-validation-for-estimation-of-oral-hypoglycaemic-drug-dapagliflozinina-tablet-dosage-form-by-the-employment-of-rphplc/junaid-ahmed
Analytical Method Development and Validation of Prednisolone Sodium Phosphate...iosrjce
IOSR Journal of Pharmacy and Biological Sciences(IOSR-JPBS) is a double blind peer reviewed International Journal that provides rapid publication (within a month) of articles in all areas of Pharmacy and Biological Science. The journal welcomes publications of high quality papers on theoretical developments and practical applications in Pharmacy and Biological Science. Original research papers, state-of-the-art reviews, and high quality technical notes are invited for publications.
Stability indicating RP-HPLC method for estimation of dapagliflozin in bulk a...SriramNagarajan19
A simple, specific, accurate, precise and stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method is developed for estimation of Dapagliflozin (DGF) in bulk and Pharmaceutical dosage form. The method employed, Hypersil BDS C18 250 mm x 4.6 mm, 5 mm column in isocratic mode with mobile phase of 0.1% Ortho phosphoric acid buffer and acetonitrile 50:50% v/v. The flow rate was 1.0 mL min-1 and effluent was monitored at 245 nm using PDA detector. The injection volume was 10 µl and the total runtime was set as 5min. The retention time for DGF was found to be 2.226min.The method was validated in terms of Linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ) etc. in accordance with ICH guidelines. Linear regression analysis data for the calibration plot showed that there was a good linear relationship between response and concentration in the range of 25 - 150 µg/ml respectively. The LOD and LOQ values for HPLC method were found to be 0.04 and 0.121 µg/ml respectively. No chromatographic interference from the tablet excipients was found. The proposed method was successfully used for estimation of Dapagliflozin (DGF) in Bulk and Pharmaceutical dosage form.
Method Development and Validation of Clopidogrel Bisulphate by Reverse Phase-...SriramNagarajan15
A new, simple sensitive, rapid, accurate and precise RP-HPLC method was developed for the estimation of Clopidogrel bisulphate in bulk drug and pharmaceutical formulation. Clopidogrel bisulphate was chromatographed on a reverse phase C18column (150 mm x 4.5 mm, i.d 5μm) in a mobile phase consisting of acetonitrile and phosphate buffer (pH: 3.0) in the ratio of 60:40 % v/v. The mobile phase was pumped at a flow rate of 1 ml/min with detection at 224 nm. The detector response was linear in the concentration of 50-150 μg /ml. The limit of detection and limit of quantitation was found to be 1.3 and 4.2 µg/ml, respectively. The intra and inter day variation was found to be less than 2%. The mean recovery of the drug from the solution was 99.79%. The proposed method is simple, fast, accurate, precise and reproducible hence, it can be applied for routine quality control analysis of Clopidogrel bisulphate in bulk drug and pharmaceutical formulation. Key words: Clopidogrel bisulphate, RP-HPLC, Validation, Accuracy, Precision.
Method Development and Validation of Clopidogrel Bisulphate by Reverse Phase-...SriramNagarajan15
A new, simple sensitive, rapid, accurate and precise RP-HPLC method was developed for the estimation of Clopidogrel bisulphate in bulk drug and pharmaceutical formulation. Clopidogrel bisulphate was chromatographed on a reverse phase C18column (150 mm x 4.5 mm, i.d 5μm) in a mobile phase consisting of acetonitrile and phosphate buffer (pH: 3.0) in the ratio of 60:40 % v/v. The mobile phase was pumped at a flow rate of 1 ml/min with detection at 224 nm. The detector response was linear in the concentration of 50-150 μg /ml. The limit of detection and limit of quantitation was found to be 1.3 and 4.2 µg/ml, respectively. The intra and inter day variation was found to be less than 2%. The mean recovery of the drug from the solution was 99.79%. The proposed method is simple, fast, accurate, precise and reproducible hence, it can be applied for routine quality control analysis of Clopidogrel bisulphate in bulk drug and pharmaceutical formulation. Key words: Clopidogrel bisulphate, RP-HPLC, Validation, Accuracy, Precision.
Development and Validation of HPLC Method for Estimation of Gliclazide in Gli...ijtsrd
A simple, selective, linear, precise and accurate HPLC method was developed and validated for the estimation of Gliclazide in Gliclazide tablets prepared using natural super disintegrant by direct compression method. Isocratic elution at a flow rate of 1.0 mL min was employed on HiQSil C18 250 mm × 4.6 mm, 5 µm column at ambient temperature using Methanol Phosphate Buffer 60 40 v v as mobile phase. The UV detection wavelength was carried out at 210nm. The linearity of the developed method was studied over the concentration ranges between 10 30µg ml. The retention time for Gliclazide was 3.2 min. The developed method was validated as per the ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. The Minimum concentration level at which the analyte can be reliable detected LOD and quantified LOQ were found to be 0.54 and 1.15 µg ml respectively. The proposed method can be successfully applied for the estimation of Gliclazide in pharmaceutical dosage forms. Mr. Kiran Madde | Dr. Ravindra Patil | Dr. Amit Kasbe "Development and Validation of HPLC Method for Estimation of Gliclazide in Gliclazide Tablets Prepared using Natural Disintegrant" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-4 , June 2022, URL: https://www.ijtsrd.com/papers/ijtsrd50403.pdf Paper URL: https://www.ijtsrd.com/humanities-and-the-arts/education/50403/development-and-validation-of-hplc-method-for-estimation-of-gliclazide-in-gliclazide-tablets-prepared-using-natural-disintegrant/mr-kiran-madde
Analytical method development and validation for the estimation of quinapril ...SriramNagarajan19
A simple and selective LC method is described for the determination of Quinapril and Tolcapone tablet dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a Mixed Phosphate buffer (KH2PO4 +K2HPO4): Acetonitrile 40:60, with detection of 239 nm. Linearity was observed in the range 50 - 150 µg /ml for Quinapril (r2 =0.995) and 62.5- 187.5µg /ml for Tolcapone (r2 =0.999) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim.
The proposed methods were validated. The accuracy of the methods was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical dosage form.
Development and Validation of Reversed Phase-High-Performance Liquid Chromato...BRNSS Publication Hub
A simple, accurate, precise, and robust in vitro methods developed and validated for measurement of drug release in Aminocaproic Acid tablets. High-performance liquid chromatography (HPLC) method for quantification of drug in dissolution samples of Aminocaproic Acid tablet is developed and validated. 0.1 N Hydrochloric acid is used as dissolution medium and Basket (USP-I) as apparatus at 100 rpm. The sample was withdrawn after 60 min. The developed HPLC method was used for quantitative estimation of drug release in dissolution samples of Aminocaproic Acid tablet. Chromatogram was run through Inertsil ODS 3V, (250 × 4.6 mm), 5 μm. Mobile phase containing buffer solution and methanol in the pumped through column at a flow rate of 1 ml/min. Buffer used in this method was 13.3 g sodium dihydrogen phosphate monohydrate, 500 mg of Heptane-1-sulfonic acid sodium salt, and 1.0 mL of Triethylamine buffer with pH 2.20 adjusted by orthophosphoric acid. Optimized wavelength for Aminocaproic acid was 210 nm. Retention time of Aminocaproic acid was found about 4.0 min; linearity range was 132.605 μg/ml–828.787 μg/ml. The new method was evaluated according to ICH guideline and as far as validation results are concern correlation coefficient value was 0.9999 for the very compound, percentage recovery 100.0%, repeatability results relative standard deviation 0.9 for Aminocaproic acid. The developed HPLC method was found to be a simple and rapid one for regular analysis in professional laboratory.
Stability indicating method development and validation for the simultaneous e...pharmaindexing
Stability indicating method development and validation for the simultaneous estimation of rabeprazole sodium and ketorolac tromethamine in bulk and synthetic mixture by RP-HPLC
Structural elucidation, Identification, quantization of process related impur...IOSR Journals
Major process related unknown impurity associated with the synthesis of Hydralazine hydrochloride bulk drug was detected by high performance liquid chromatography (HPLC) and was subjected to high resolution accurate liquid chromatography mass spectroscopy (HR/AM-LCMS) for identification. The proposed impurity was isolated from Hydralazine hydrochloride active pharmaceutical ingredient (API) by preparative chromatographic method and was injected on HPLC for comparison of retention time with that of the unknown process related impurity in Hydralazine hydrochloride. The molecular ion peak of preparatively isolated impurity and that of unknown process related impurity in Hydralazine hydrochloride were compared for confirmation. The postulated structure was unambiguously confirmed with the help of HR/AM- LC MS/MS, NMR and FTIR data proposed to be 1-(2-phthalazin-1-ylhydrazino)phthalazine (Hazh Dimer). This impurity of Hydralazine hydrochloride is not been previously reported. A rapid Acquity H-class gradient method with runtime of 15.0min was developed for Quantitation on Unisphere Cyno column and validated for parameters such as accuracy, precision, linearity and range, robustness. The LOD and LOQ of method were 0081% and 0.0246% respectively.
Formulation and Evaluation of Solid dispersion for Dissolution Enhancement of...Jing Zang
Nifedipine, a calcium channel blocker antihypertensive drug, is a poorly water soluble drug and belongs to BCS class II. The objective of the research work was to formulate and optimize solid dispersions (SDs) of a poorly water soluble drug, nifedipine, with sodium starch glycollate, croscarmellose sodium, eudragit E-100. Solid dispersions were prepared by solvent evaporation techniques in different weight ratios of polymers. The results indicated that homogeneous or heterogeneous conditions during the preparation methods employed governed the internal structures of the polymer matrices while retaining the drug in an amorphous form. The physical mixtures and solid dispersions were subjected to drug content and dissolution test. The best formulation, nifedipine with croscarmellose sodium in 1:7 ratio, among all was further adsorbed on neusilin US2 to form ternary mixture. The increased dissolution was achieved by more than 70percent and 30percent comparatively to the nifedipine API and marketed product respectively. The tablet dosage form prepared from ternary mixture was stable at stressed conditions 40±2°C and 75±5% RH. The release kinetics of drug from formulation and marketed product follows peppas model. The similar factor f2 was within limit for the product at stressed conditions with the product at room temperature at the same time.
DEVELOPMENT AND VALIDATION OF SPECTROSCOPIC AND CHROMATOGRAPHIC METHOD FOR D...Dipak Reddy
A simple, precise & accurate UV spectroscopy & HPLC method was developed & validated as per ICH guideline.
In UV spectroscopy 0.1HCL used as diluent & in HPLC Methanol :ortho phosphoric acid (40:60%v/v) used.
Thus based on validation data it is concluded that present method is economical, less time consuming, precise , accurate for estimation of Pioglitazone in bulk drug & formulations.
This method can be used to determine the purity of the drug available from various sources by detecting the related impurities.
Quality-by-design-based development and validation of a stability-indicating ...Ratnakaram Venkata Nadh
A systematic design-of-experiments was performed by applying quality-by-design concepts to determine
design space for rapid quantification of teriflunomide by the ultraperformance liquid chromatography
(UPLC) method in the presence of degradation products. Response surface and central composite
quadratic were used for statistical evaluation of experimental data using a Design-Expert software. The
response variables such as resolution, retention time, and peak tailing were analyzed statistically for the
screening of suitable chromatographic conditions. During this process, various plots such as perturbation,
contour, 3D, and design space were studied. The method was developed through UPLC BEH C18
2.1 � 100 mm, 1.7-μ column, mobile phase comprised of buffer (5 mM K2HPO4 containing 0.1%
triethylamine, pH 6.8), and acetonitrile (40:60 v/v), the flow rate of 0.5 mL min 1 and UV detection at
250 nm. The method was developed with a short run time of 1 min. Forced degradation studies revealed
that the method was stability-indicating, suitable for both assay and in-vitro dissolution of a drug product.
The method was found to be linear in the range of 28–84 μg mL 1, 2.8–22.7 μg mL 1 with a correlation
coefficient of 0.9999 and 1.000 for assay and dissolution, respectively. The recovery values were found in
the range of 100.1–101.7%. The method was validated according to ICH guidelines.
‘Six Sigma Technique’ A Journey Through its Implementationijtsrd
The manufacturing industries all over the world are facing tough challenges for growth, development and sustainability in today’s competitive environment. They have to achieve apex position by adapting with the global competitive environment by delivering goods and services at low cost, prime quality and better price to increase wealth and consumer satisfaction. Cost Management ensures profit, growth and sustainability of the business with implementation of Continuous Improvement Technique like Six Sigma. This leads to optimize Business performance. The method drives for customer satisfaction, low variation, reduction in waste and cycle time resulting into a competitive advantage over other industries which did not implement it. The main objective of this paper ‘Six Sigma Technique A Journey Through Its Implementation’ is to conceptualize the effectiveness of Six Sigma Technique through the journey of its implementation. Aditi Sunilkumar Ghosalkar "‘Six Sigma Technique’: A Journey Through its Implementation" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64546.pdf Paper Url: https://www.ijtsrd.com/other-scientific-research-area/other/64546/‘six-sigma-technique’-a-journey-through-its-implementation/aditi-sunilkumar-ghosalkar
Edge Computing in Space Enhancing Data Processing and Communication for Space...ijtsrd
Edge computing, a paradigm that involves processing data closer to its source, has gained significant attention for its potential to revolutionize data processing and communication in space missions. With the increasing complexity and data volume generated by modern space missions, traditional centralized computing approaches face challenges related to latency, bandwidth, and security. Edge computing in space, involving on board processing and analysis of data, offers promising solutions to these challenges. This paper explores the concept of edge computing in space, its benefits, applications, and future prospects in enhancing space missions. Manish Verma "Edge Computing in Space: Enhancing Data Processing and Communication for Space Missions" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64541.pdf Paper Url: https://www.ijtsrd.com/computer-science/artificial-intelligence/64541/edge-computing-in-space-enhancing-data-processing-and-communication-for-space-missions/manish-verma
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Development and Validation of HPLC Method for Estimation of Gliclazide in Gli...ijtsrd
A simple, selective, linear, precise and accurate HPLC method was developed and validated for the estimation of Gliclazide in Gliclazide tablets prepared using natural super disintegrant by direct compression method. Isocratic elution at a flow rate of 1.0 mL min was employed on HiQSil C18 250 mm × 4.6 mm, 5 µm column at ambient temperature using Methanol Phosphate Buffer 60 40 v v as mobile phase. The UV detection wavelength was carried out at 210nm. The linearity of the developed method was studied over the concentration ranges between 10 30µg ml. The retention time for Gliclazide was 3.2 min. The developed method was validated as per the ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. The Minimum concentration level at which the analyte can be reliable detected LOD and quantified LOQ were found to be 0.54 and 1.15 µg ml respectively. The proposed method can be successfully applied for the estimation of Gliclazide in pharmaceutical dosage forms. Mr. Kiran Madde | Dr. Ravindra Patil | Dr. Amit Kasbe "Development and Validation of HPLC Method for Estimation of Gliclazide in Gliclazide Tablets Prepared using Natural Disintegrant" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-4 , June 2022, URL: https://www.ijtsrd.com/papers/ijtsrd50403.pdf Paper URL: https://www.ijtsrd.com/humanities-and-the-arts/education/50403/development-and-validation-of-hplc-method-for-estimation-of-gliclazide-in-gliclazide-tablets-prepared-using-natural-disintegrant/mr-kiran-madde
Analytical method development and validation for the estimation of quinapril ...SriramNagarajan19
A simple and selective LC method is described for the determination of Quinapril and Tolcapone tablet dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a Mixed Phosphate buffer (KH2PO4 +K2HPO4): Acetonitrile 40:60, with detection of 239 nm. Linearity was observed in the range 50 - 150 µg /ml for Quinapril (r2 =0.995) and 62.5- 187.5µg /ml for Tolcapone (r2 =0.999) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim.
The proposed methods were validated. The accuracy of the methods was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical dosage form.
Development and Validation of Reversed Phase-High-Performance Liquid Chromato...BRNSS Publication Hub
A simple, accurate, precise, and robust in vitro methods developed and validated for measurement of drug release in Aminocaproic Acid tablets. High-performance liquid chromatography (HPLC) method for quantification of drug in dissolution samples of Aminocaproic Acid tablet is developed and validated. 0.1 N Hydrochloric acid is used as dissolution medium and Basket (USP-I) as apparatus at 100 rpm. The sample was withdrawn after 60 min. The developed HPLC method was used for quantitative estimation of drug release in dissolution samples of Aminocaproic Acid tablet. Chromatogram was run through Inertsil ODS 3V, (250 × 4.6 mm), 5 μm. Mobile phase containing buffer solution and methanol in the pumped through column at a flow rate of 1 ml/min. Buffer used in this method was 13.3 g sodium dihydrogen phosphate monohydrate, 500 mg of Heptane-1-sulfonic acid sodium salt, and 1.0 mL of Triethylamine buffer with pH 2.20 adjusted by orthophosphoric acid. Optimized wavelength for Aminocaproic acid was 210 nm. Retention time of Aminocaproic acid was found about 4.0 min; linearity range was 132.605 μg/ml–828.787 μg/ml. The new method was evaluated according to ICH guideline and as far as validation results are concern correlation coefficient value was 0.9999 for the very compound, percentage recovery 100.0%, repeatability results relative standard deviation 0.9 for Aminocaproic acid. The developed HPLC method was found to be a simple and rapid one for regular analysis in professional laboratory.
Stability indicating method development and validation for the simultaneous e...pharmaindexing
Stability indicating method development and validation for the simultaneous estimation of rabeprazole sodium and ketorolac tromethamine in bulk and synthetic mixture by RP-HPLC
Structural elucidation, Identification, quantization of process related impur...IOSR Journals
Major process related unknown impurity associated with the synthesis of Hydralazine hydrochloride bulk drug was detected by high performance liquid chromatography (HPLC) and was subjected to high resolution accurate liquid chromatography mass spectroscopy (HR/AM-LCMS) for identification. The proposed impurity was isolated from Hydralazine hydrochloride active pharmaceutical ingredient (API) by preparative chromatographic method and was injected on HPLC for comparison of retention time with that of the unknown process related impurity in Hydralazine hydrochloride. The molecular ion peak of preparatively isolated impurity and that of unknown process related impurity in Hydralazine hydrochloride were compared for confirmation. The postulated structure was unambiguously confirmed with the help of HR/AM- LC MS/MS, NMR and FTIR data proposed to be 1-(2-phthalazin-1-ylhydrazino)phthalazine (Hazh Dimer). This impurity of Hydralazine hydrochloride is not been previously reported. A rapid Acquity H-class gradient method with runtime of 15.0min was developed for Quantitation on Unisphere Cyno column and validated for parameters such as accuracy, precision, linearity and range, robustness. The LOD and LOQ of method were 0081% and 0.0246% respectively.
Formulation and Evaluation of Solid dispersion for Dissolution Enhancement of...Jing Zang
Nifedipine, a calcium channel blocker antihypertensive drug, is a poorly water soluble drug and belongs to BCS class II. The objective of the research work was to formulate and optimize solid dispersions (SDs) of a poorly water soluble drug, nifedipine, with sodium starch glycollate, croscarmellose sodium, eudragit E-100. Solid dispersions were prepared by solvent evaporation techniques in different weight ratios of polymers. The results indicated that homogeneous or heterogeneous conditions during the preparation methods employed governed the internal structures of the polymer matrices while retaining the drug in an amorphous form. The physical mixtures and solid dispersions were subjected to drug content and dissolution test. The best formulation, nifedipine with croscarmellose sodium in 1:7 ratio, among all was further adsorbed on neusilin US2 to form ternary mixture. The increased dissolution was achieved by more than 70percent and 30percent comparatively to the nifedipine API and marketed product respectively. The tablet dosage form prepared from ternary mixture was stable at stressed conditions 40±2°C and 75±5% RH. The release kinetics of drug from formulation and marketed product follows peppas model. The similar factor f2 was within limit for the product at stressed conditions with the product at room temperature at the same time.
DEVELOPMENT AND VALIDATION OF SPECTROSCOPIC AND CHROMATOGRAPHIC METHOD FOR D...Dipak Reddy
A simple, precise & accurate UV spectroscopy & HPLC method was developed & validated as per ICH guideline.
In UV spectroscopy 0.1HCL used as diluent & in HPLC Methanol :ortho phosphoric acid (40:60%v/v) used.
Thus based on validation data it is concluded that present method is economical, less time consuming, precise , accurate for estimation of Pioglitazone in bulk drug & formulations.
This method can be used to determine the purity of the drug available from various sources by detecting the related impurities.
Quality-by-design-based development and validation of a stability-indicating ...Ratnakaram Venkata Nadh
A systematic design-of-experiments was performed by applying quality-by-design concepts to determine
design space for rapid quantification of teriflunomide by the ultraperformance liquid chromatography
(UPLC) method in the presence of degradation products. Response surface and central composite
quadratic were used for statistical evaluation of experimental data using a Design-Expert software. The
response variables such as resolution, retention time, and peak tailing were analyzed statistically for the
screening of suitable chromatographic conditions. During this process, various plots such as perturbation,
contour, 3D, and design space were studied. The method was developed through UPLC BEH C18
2.1 � 100 mm, 1.7-μ column, mobile phase comprised of buffer (5 mM K2HPO4 containing 0.1%
triethylamine, pH 6.8), and acetonitrile (40:60 v/v), the flow rate of 0.5 mL min 1 and UV detection at
250 nm. The method was developed with a short run time of 1 min. Forced degradation studies revealed
that the method was stability-indicating, suitable for both assay and in-vitro dissolution of a drug product.
The method was found to be linear in the range of 28–84 μg mL 1, 2.8–22.7 μg mL 1 with a correlation
coefficient of 0.9999 and 1.000 for assay and dissolution, respectively. The recovery values were found in
the range of 100.1–101.7%. The method was validated according to ICH guidelines.
Similar to Method Development, Validation and Forced Degradation Studies of Dapagliflozin and Pioglitazone Hydrochlorides in Synthetic Mixtures by RP HPLC (20)
‘Six Sigma Technique’ A Journey Through its Implementationijtsrd
The manufacturing industries all over the world are facing tough challenges for growth, development and sustainability in today’s competitive environment. They have to achieve apex position by adapting with the global competitive environment by delivering goods and services at low cost, prime quality and better price to increase wealth and consumer satisfaction. Cost Management ensures profit, growth and sustainability of the business with implementation of Continuous Improvement Technique like Six Sigma. This leads to optimize Business performance. The method drives for customer satisfaction, low variation, reduction in waste and cycle time resulting into a competitive advantage over other industries which did not implement it. The main objective of this paper ‘Six Sigma Technique A Journey Through Its Implementation’ is to conceptualize the effectiveness of Six Sigma Technique through the journey of its implementation. Aditi Sunilkumar Ghosalkar "‘Six Sigma Technique’: A Journey Through its Implementation" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64546.pdf Paper Url: https://www.ijtsrd.com/other-scientific-research-area/other/64546/‘six-sigma-technique’-a-journey-through-its-implementation/aditi-sunilkumar-ghosalkar
Edge Computing in Space Enhancing Data Processing and Communication for Space...ijtsrd
Edge computing, a paradigm that involves processing data closer to its source, has gained significant attention for its potential to revolutionize data processing and communication in space missions. With the increasing complexity and data volume generated by modern space missions, traditional centralized computing approaches face challenges related to latency, bandwidth, and security. Edge computing in space, involving on board processing and analysis of data, offers promising solutions to these challenges. This paper explores the concept of edge computing in space, its benefits, applications, and future prospects in enhancing space missions. Manish Verma "Edge Computing in Space: Enhancing Data Processing and Communication for Space Missions" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64541.pdf Paper Url: https://www.ijtsrd.com/computer-science/artificial-intelligence/64541/edge-computing-in-space-enhancing-data-processing-and-communication-for-space-missions/manish-verma
Dynamics of Communal Politics in 21st Century India Challenges and Prospectsijtsrd
Communal politics in India has evolved through centuries, weaving a complex tapestry shaped by historical legacies, colonial influences, and contemporary socio political transformations. This research comprehensively examines the dynamics of communal politics in 21st century India, emphasizing its historical roots, socio political dynamics, economic implications, challenges, and prospects for mitigation. The historical perspective unravels the intricate interplay of religious identities and power dynamics from ancient civilizations to the impact of colonial rule, providing insights into the evolution of communalism. The socio political dynamics section delves into the contemporary manifestations, exploring the roles of identity politics, socio economic disparities, and globalization. The economic implications section highlights how communal politics intersects with economic issues, perpetuating disparities and influencing resource allocation. Challenges posed by communal politics are scrutinized, revealing multifaceted issues ranging from social fragmentation to threats against democratic values. The prospects for mitigation present a multifaceted approach, incorporating policy interventions, community engagement, and educational initiatives. The paper conducts a comparative analysis with international examples, identifying common patterns such as identity politics and economic disparities. It also examines unique challenges, emphasizing Indias diverse religious landscape, historical legacy, and secular framework. Lessons for effective strategies are drawn from international experiences, offering insights into inclusive policies, interfaith dialogue, media regulation, and global cooperation. By scrutinizing historical epochs, contemporary dynamics, economic implications, and international comparisons, this research provides a comprehensive understanding of communal politics in India. The proposed strategies for mitigation underscore the importance of a holistic approach to foster social harmony, inclusivity, and democratic values. Rose Hossain "Dynamics of Communal Politics in 21st Century India: Challenges and Prospects" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64528.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/history/64528/dynamics-of-communal-politics-in-21st-century-india-challenges-and-prospects/rose-hossain
Assess Perspective and Knowledge of Healthcare Providers Towards Elehealth in...ijtsrd
Background and Objective Telehealth has become a well known tool for the delivery of health care in Saudi Arabia, and the perspective and knowledge of healthcare providers are influential in the implementation, adoption and advancement of the method. This systematic review was conducted to examine the current literature base regarding telehealth and the related healthcare professional perspective and knowledge in the Kingdom of Saudi Arabia. Materials and Methods This systematic review was conducted by searching 7 databases including, MEDLINE, CINHAL, Web of Science, Scopus, PubMed, PsycINFO, and ProQuest Central. Studies on healthcare practitioners telehealth knowledge and perspectives published in English in Saudi Arabia from 2000 to 2023 were included. Boland directed this comprehensive review. The researchers examined each connected study using the AXIS tool, which evaluates cross sectional systematic reviews. Narrative synthesis was used to summarise and convey the data. Results Out of 1840 search results, 10 studies were included. Positive outlook and limited knowledge among providers were seen across trials. Healthcare professionals like telehealth for its ability to improve quality, access, and delivery, save time and money, and be successful. Age, gender, occupation, and work experience also affect health workers knowledge. In Saudi Arabia, healthcare professionals face inadequate expert assistance, patient privacy, internet connection concerns, lack of training courses, lack of telehealth understanding, and high costs while performing telemedicine. Conclusions Healthcare practitioners telehealth perceptions and knowledge were examined in this systematic study. Its collection of concerned experts different personal attitudes and expertise would help enhance telehealths implementation in Saudi Arabia, develop its healthcare delivery alternative, and eliminate frequent problems. Badriah Mousa I Mulayhi | Dr. Jomin George | Judy Jenkins "Assess Perspective and Knowledge of Healthcare Providers Towards Elehealth in Saudi Arabia: A Systematic Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64535.pdf Paper Url: https://www.ijtsrd.com/medicine/other/64535/assess-perspective-and-knowledge-of-healthcare-providers-towards-elehealth-in-saudi-arabia-a-systematic-review/badriah-mousa-i-mulayhi
The Impact of Digital Media on the Decentralization of Power and the Erosion ...ijtsrd
The impact of digital media on the distribution of power and the weakening of traditional gatekeepers has gained considerable attention in recent years. The adoption of digital technologies and the internet has resulted in declining influence and power for traditional gatekeepers such as publishing houses and news organizations. Simultaneously, digital media has facilitated the emergence of new voices and players in the media industry. Digital medias impact on power decentralization and gatekeeper erosion is visible in several ways. One significant aspect is the democratization of information, which enables anyone with an internet connection to publish and share content globally, leading to citizen journalism and bypassing traditional gatekeepers. Another aspect is the disruption of conventional media industry business models, as traditional organizations struggle to adjust to the decrease in advertising revenue and the rise of digital platforms. Alternative business models, such as subscription models and crowdfunding, have become more prevalent, leading to the emergence of new players. Overall, the impact of digital media on the distribution of power and the weakening of traditional gatekeepers has brought about significant changes in the media landscape and the way information is shared. Further research is required to fully comprehend the implications of these changes and their impact on society. Dr. Kusum Lata "The Impact of Digital Media on the Decentralization of Power and the Erosion of Traditional Gatekeepers" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64544.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/political-science/64544/the-impact-of-digital-media-on-the-decentralization-of-power-and-the-erosion-of-traditional-gatekeepers/dr-kusum-lata
Online Voices, Offline Impact Ambedkars Ideals and Socio Political Inclusion ...ijtsrd
This research investigates the nexus between online discussions on Dr. B.R. Ambedkars ideals and their impact on social inclusion among college students in Gurugram, Haryana. Surveying 240 students from 12 government colleges, findings indicate that 65 actively engage in online discussions, with 80 demonstrating moderate to high awareness of Ambedkars ideals. Statistically significant correlations reveal that higher online engagement correlates with increased awareness p 0.05 and perceived social inclusion. Variations across colleges and a notable effect of college type on perceived social inclusion highlight the influence of contextual factors. Furthermore, the intersectional analysis underscores nuanced differences based on gender, caste, and socio economic status. Dr. Kusum Lata "Online Voices, Offline Impact: Ambedkar's Ideals and Socio-Political Inclusion - A Study of Gurugram District" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64543.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/political-science/64543/online-voices-offline-impact-ambedkars-ideals-and-sociopolitical-inclusion--a-study-of-gurugram-district/dr-kusum-lata
Problems and Challenges of Agro Entreprenurship A Studyijtsrd
Noting calls for contextualizing Agro entrepreneurs problems and challenges of the agro entrepreneurs and for greater attention to the Role of entrepreneurs in agro entrepreneurship research, we conduct a systematic literature review of extent research in agriculture entrepreneurship to overcome the study objectives of complications of agro entrepreneurs through various factors, Development of agriculture products is a key factor for the overall economic growth of agro entrepreneurs Agro Entrepreneurs produces firsthand large scale employment, utilizes the labor and natural resources, This research outlines the problems of Weather and Soil Erosions, Market price fluctuation, stimulates labor cost problems, reduces concentration of Price volatility, Dependency on Intermediaries, induces Limited Bargaining Power, and Storage and Transportation Costs. This paper mainly devoted to highlight Problems and challenges faced for the sustainable of Agro Entrepreneurs in India. Vinay Prasad B "Problems and Challenges of Agro Entreprenurship - A Study" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64540.pdf Paper Url: https://www.ijtsrd.com/other-scientific-research-area/other/64540/problems-and-challenges-of-agro-entreprenurship--a-study/vinay-prasad-b
Comparative Analysis of Total Corporate Disclosure of Selected IT Companies o...ijtsrd
Disclosure is a process through which a business enterprise communicates with external parties. A corporate disclosure is communication of financial and non financial information of the activities of a business enterprise to the interested entities. Corporate disclosure is done through publishing annual reports. So corporate disclosure through annual reports plays a vital role in the life of all the companies and provides valuable information to investors. The basic objectives of corporate disclosure is to give a true and fair view of companies to the parties related either directly or indirectly like owner, government, creditors, shareholders etc. in the companies act, provisions have been made about mandatory and voluntary disclosure. The IT sector in India is rapidly growing, the trend to invest in the IT sector is rising and employment opportunities in IT sectors are also increasing. Therefore the IT sector is expected to have fair, full and adequate disclosure of all information. Unfair and incomplete disclosure may adversely affect the entire economy. A research study on disclosure practices of IT companies could play an important role in this regard. Hence, the present research study has been done to study and review comparative analysis of total corporate disclosure of selected IT companies of India and to put forward overall findings and suggestions with a view to increase disclosure score of these companies. The researcher hopes that the present research study will be helpful to all selected Companies for improving level of corporate disclosure through annual reports as well as the government, creditors, investors, all business organizations and upcoming researcher for comparative analyses of level of corporate disclosure with special reference to selected IT companies. Dr. Vaibhavi D. Thaker "Comparative Analysis of Total Corporate Disclosure of Selected IT Companies of India" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64539.pdf Paper Url: https://www.ijtsrd.com/other-scientific-research-area/other/64539/comparative-analysis-of-total-corporate-disclosure-of-selected-it-companies-of-india/dr-vaibhavi-d-thaker
The Impact of Educational Background and Professional Training on Human Right...ijtsrd
This study investigated the impact of educational background and professional training on human rights awareness among secondary school teachers in the Marathwada region of Maharashtra, India. The key findings reveal that higher levels of education, particularly a master’s degree, and fields of study related to education, humanities, or social sciences are associated with greater human rights awareness among teachers. Additionally, both pre service teacher training and in service professional development programs focused on human rights education significantly enhance teacher’s knowledge, skills, and competencies in promoting human rights principles in their classrooms. Baig Ameer Bee Mirza Abdul Aziz | Dr. Syed Azaz Ali Amjad Ali "The Impact of Educational Background and Professional Training on Human Rights Awareness among Secondary School Teachers" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64529.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/education/64529/the-impact-of-educational-background-and-professional-training-on-human-rights-awareness-among-secondary-school-teachers/baig-ameer-bee-mirza-abdul-aziz
A Study on the Effective Teaching Learning Process in English Curriculum at t...ijtsrd
“One Language sets you in a corridor for life. Two languages open every door along the way” Frank Smith English as a foreign language or as a second language has been ruling in India since the period of Lord Macaulay. But the question is how much we teach or learn English properly in our culture. Is there any scope to use English as a language rather than a subject How much we learn or teach English without any interference of mother language specially in the classroom teaching learning scenario in West Bengal By considering all these issues the researcher has attempted in this article to focus on the effective teaching learning process comparing to other traditional strategies in the field of English curriculum at the secondary level to investigate whether they fulfill the present teaching learning requirements or not by examining the validity of the present curriculum of English. The purpose of this study is to focus on the effectiveness of the systematic, scientific, sequential and logical transaction of the course between the teachers and the learners in the perspective of the 5Es programme that is engage, explore, explain, extend and evaluate. Sanchali Mondal | Santinath Sarkar "A Study on the Effective Teaching Learning Process in English Curriculum at the Secondary Level of West Bengal" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd62412.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/education/62412/a-study-on-the-effective-teaching-learning-process-in-english-curriculum-at-the-secondary-level-of-west-bengal/sanchali-mondal
The Role of Mentoring and Its Influence on the Effectiveness of the Teaching ...ijtsrd
This paper reports on a study which was conducted to investigate the role of mentoring and its influence on the effectiveness of the teaching of Physics in secondary schools in the South West Region of Cameroon. The study adopted the convergent parallel mixed methods design, focusing on respondents in secondary schools in the South West Region of Cameroon. Both quantitative and qualitative data were collected, analysed separately, and the results were compared to see if the findings confirm or disconfirm each other. The quantitative analysis found that majority of the respondents 72 of Physics teachers affirmed that they had more experienced colleagues as mentors to help build their confidence, improve their teaching, and help them improve their effectiveness and efficiency in guiding learners’ achievements. Only 28 of the respondents disagreed with these statements. With majority respondents 72 agreeing with the statements, it implies that in most secondary schools, experienced Physics teachers act as mentors to build teachers’ confidence in teaching and improving students’ learning. The interview qualitative data analysis summarized how secondary school Principals use meetings with mentors and mentees to promote mentorship in the school milieu. This has helped strengthen teachers’ classroom practices in secondary schools in the South West Region of Cameroon. With the results confirming each other, the study recommends that mentoring should focus on helping teachers employ social interactions and instructional practices feedback and clarity in teaching that have direct measurable impact on students’ learning achievements. Andrew Ngeim Sumba | Frederick Ebot Ashu | Peter Agborbechem Tambi "The Role of Mentoring and Its Influence on the Effectiveness of the Teaching of Physics in Secondary Schools in the South West Region of Cameroon" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64524.pdf Paper Url: https://www.ijtsrd.com/management/management-development/64524/the-role-of-mentoring-and-its-influence-on-the-effectiveness-of-the-teaching-of-physics-in-secondary-schools-in-the-south-west-region-of-cameroon/andrew-ngeim-sumba
Design Simulation and Hardware Construction of an Arduino Microcontroller Bas...ijtsrd
This study primarily focuses on the design of a high side buck converter using an Arduino microcontroller. The converter is specifically intended for use in DC DC applications, particularly in standalone solar PV systems where the PV output voltage exceeds the load or battery voltage. To evaluate the performance of the converter, simulation experiments are conducted using Proteus Software. These simulations provide insights into the input and output voltages, currents, powers, and efficiency under different state of charge SoC conditions of a 12V,70Ah rechargeable lead acid battery. Additionally, the hardware design of the converter is implemented, and practical data is collected through operation, monitoring, and recording. By comparing the simulation results with the practical results, the efficiency and performance of the designed converter are assessed. The findings indicate that while the buck converter is suitable for practical use in standalone PV systems, its efficiency is compromised due to a lower output current. Chan Myae Aung | Dr. Ei Mon "Design Simulation and Hardware Construction of an Arduino-Microcontroller Based DC-DC High-Side Buck Converter for Standalone PV System" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64518.pdf Paper Url: https://www.ijtsrd.com/engineering/mechanical-engineering/64518/design-simulation-and-hardware-construction-of-an-arduinomicrocontroller-based-dcdc-highside-buck-converter-for-standalone-pv-system/chan-myae-aung
Sustainable Energy by Paul A. Adekunte | Matthew N. O. Sadiku | Janet O. Sadikuijtsrd
Energy becomes sustainable if it meets the needs of the present without compromising the ability of future generations to meet their own needs. Some of the definitions of sustainable energy include the considerations of environmental aspects such as greenhouse gas emissions, social, and economic aspects such as energy poverty. Generally far more sustainable than fossil fuel are renewable energy sources such as wind, hydroelectric power, solar, and geothermal energy sources. Worthy of note is that some renewable energy projects, like the clearing of forests to produce biofuels, can cause severe environmental damage. The sustainability of nuclear power which is a low carbon source is highly debated because of concerns about radioactive waste, nuclear proliferation, and accidents. The switching from coal to natural gas has environmental benefits, including a lower climate impact, but could lead to delay in switching to more sustainable options. “Carbon capture and storage” can be built into power plants to remove the carbon dioxide CO2 emissions, but this technology is expensive and has rarely been implemented. Leading non renewable energy sources around the world is fossil fuels, coal, petroleum, and natural gas. Nuclear energy is usually considered another non renewable energy source, although nuclear energy itself is a renewable energy source, but the material used in nuclear power plants is not. The paper addresses the issue of sustainable energy, its attendant benefits to the future generation, and humanity in general. Paul A. Adekunte | Matthew N. O. Sadiku | Janet O. Sadiku "Sustainable Energy" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64534.pdf Paper Url: https://www.ijtsrd.com/engineering/electrical-engineering/64534/sustainable-energy/paul-a-adekunte
Concepts for Sudan Survey Act Implementations Executive Regulations and Stand...ijtsrd
This paper aims to outline the executive regulations, survey standards, and specifications required for the implementation of the Sudan Survey Act, and for regulating and organizing all surveying work activities in Sudan. The act has been discussed for more than 5 years. The Land Survey Act was initiated by the Sudan Survey Authority and all official legislations were headed by the Sudan Ministry of Justice till it was issued in 2022. The paper presents conceptual guidelines to be used for the Survey Act implementation and to regulate the survey work practice, standardizing the field surveys, processing, quality control, procedures, and the processes related to survey work carried out by the stakeholders and relevant authorities in Sudan. The conceptual guidelines are meant to improve the quality and harmonization of geospatial data and to aid decision making processes as well as geospatial information systems. The established comprehensive executive regulations will govern and regulate the implementation of the Sudan Survey Geomatics Act in all surveying and mapping practices undertaken by the Sudan Survey Authority SSA and state local survey departments for public or private sector organizations. The targeted standards and specifications include the reference frame, projection, coordinate systems, and the guidelines and specifications that must be followed in the field of survey work, processes, and mapping products. In the last few decades, there has been a growing awareness of the importance of geomatics activities and measurements on the Earths surface in space and time, together with observing and mapping the changes. In such cases, data must be captured promptly, standardized, and obtained with more accuracy and specified in much detail. The paper will also highlight the current situation in Sudan, the degree to which survey standards are used, the problems encountered, and the errors that arise from not using the standards and survey specifications. Kamal A. A. Sami "Concepts for Sudan Survey Act Implementations - Executive Regulations and Standards" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63484.pdf Paper Url: https://www.ijtsrd.com/engineering/civil-engineering/63484/concepts-for-sudan-survey-act-implementations--executive-regulations-and-standards/kamal-a-a-sami
Towards the Implementation of the Sudan Interpolated Geoid Model Khartoum Sta...ijtsrd
The discussions between ellipsoid and geoid have invoked many researchers during the recent decades, especially during the GNSS technology era, which had witnessed a great deal of development but still geoid undulation requires more investigations. To figure out a solution for Sudans local geoid, this research has tried to intake the possibility of determining the geoid model by following two approaches, gravimetric and geometrical geoid model determination, by making use of GNSS leveling benchmarks at Khartoum state. The Benchmarks are well distributed in the study area, in which, the horizontal coordinates and the height above the ellipsoid have been observed by GNSS while orthometric heights were carried out using precise leveling. The Global Geopotential Model GGM represented in EGM2008 has been exploited to figure out the geoid undulation at the benchmarks in the study area. This is followed by a fitting process, that has been done to suit the geoid undulation data which has been computed using GNSS leveling data and geoid undulation inspired by the EGM2008. Two geoid surfaces were created after the fitting process to ensure that they are identical and both of them could be counted for getting the same geoid undulation with an acceptable accuracy. In this respect, statistical operation played an important role in ensuring the consistency and integrity of the model by applying cross validation techniques splitting the data into training and testing datasets for building the geoid model and testing its eligibility. The geometrical solution for geoid undulation computation has been utilized by applying straightforward equations that facilitate the calculation of the geoid undulation directly through applying statistical techniques for the GNSS leveling data of the study area to get the common equation parameters values that could be utilized to calculate geoid undulation of any position in the study area within the claimed accuracy. Both systems were checked and proved eligible to be used within the study area with acceptable accuracy which may contribute to solving the geoid undulation problem in the Khartoum area, and be further generalized to determine the geoid model over the entire country, and this could be considered in the future, for regional and continental geoid model. Ahmed M. A. Mohammed. | Kamal A. A. Sami "Towards the Implementation of the Sudan Interpolated Geoid Model (Khartoum State Case Study)" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63483.pdf Paper Url: https://www.ijtsrd.com/engineering/civil-engineering/63483/towards-the-implementation-of-the-sudan-interpolated-geoid-model-khartoum-state-case-study/ahmed-m-a-mohammed
Activating Geospatial Information for Sudans Sustainable Investment Mapijtsrd
Sudan is witnessing an acceleration in the processes of development and transformation in the performance of government institutions to raise the productivity and investment efficiency of the government sector. The development plans and investment opportunities have focused on achieving national goals in various sectors. This paper aims to illuminate the path to the future and provide geospatial data and information to develop the investment climate and environment for all sized businesses, and to bridge the development gap between the Sudan states. The Sudan Survey Authority SSA is the main advisor to the Sudan Government in conducting surveying, mappings, designing, and developing systems related to geospatial data and information. In recent years, SSA made a strategic partnership with the Ministry of Investment to activate Geospatial Information for Sudans Sustainable Investment and in particular, for the preparation and implementation of the Sudan investment map, based on the directives and objectives of the Ministry of Investment MI in Sudan. This paper comes within the framework of activating the efforts of the Ministry of Investment to develop technical investment services by applying techniques adopted by the Ministry and its strategic partners for advancing investment processes in the country. Kamal A. A. Sami "Activating Geospatial Information for Sudan's Sustainable Investment Map" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63482.pdf Paper Url: https://www.ijtsrd.com/engineering/information-technology/63482/activating-geospatial-information-for-sudans-sustainable-investment-map/kamal-a-a-sami
Educational Unity Embracing Diversity for a Stronger Societyijtsrd
In a rapidly changing global landscape, the importance of education as a unifying force cannot be overstated. This paper explores the crucial role of educational unity in fostering a stronger and more inclusive society through the embrace of diversity. By examining the benefits of diverse learning environments, the paper aims to highlight the positive impact on societal strength. The discussion encompasses various dimensions, from curriculum design to classroom dynamics, and emphasizes the need for educational institutions to become catalysts for unity in diversity. It highlights the need for a paradigm shift in educational policies, curricula, and pedagogical approaches to ensure that they are reflective of the diverse fabric of society. This paper also addresses the challenges associated with implementing inclusive educational practices and offers practical strategies for overcoming barriers. It advocates for collaborative efforts between educational institutions, policymakers, and communities to create a supportive ecosystem that promotes diversity and unity. Mr. Amit Adhikari | Madhumita Teli | Gopal Adhikari "Educational Unity: Embracing Diversity for a Stronger Society" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64525.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/education/64525/educational-unity-embracing-diversity-for-a-stronger-society/mr-amit-adhikari
Integration of Indian Indigenous Knowledge System in Management Prospects and...ijtsrd
The diversity of indigenous knowledge systems in India is vast and can vary significantly between different communities and regions. Preserving and respecting these knowledge systems is crucial for maintaining cultural heritage, promoting sustainable practices, and fostering cross cultural understanding. In this paper, an overview of the prospects and challenges associated with incorporating Indian indigenous knowledge into management is explored. It is found that IIKS helps in management in many areas like sustainable development, tourism, food security, natural resource management, cultural preservation and innovation, etc. However, IIKS integration with management faces some challenges in the form of a lack of documentation, cultural sensitivity, language barriers legal framework, etc. Savita Lathwal "Integration of Indian Indigenous Knowledge System in Management: Prospects and Challenges" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63500.pdf Paper Url: https://www.ijtsrd.com/management/accounting-and-finance/63500/integration-of-indian-indigenous-knowledge-system-in-management-prospects-and-challenges/savita-lathwal
DeepMask Transforming Face Mask Identification for Better Pandemic Control in...ijtsrd
The COVID 19 pandemic has highlighted the crucial need of preventive measures, with widespread use of face masks being a key method for slowing the viruss spread. This research investigates face mask identification using deep learning as a technological solution to be reducing the risk of coronavirus transmission. The proposed method uses state of the art convolutional neural networks CNNs and transfer learning to automatically recognize persons who are not wearing masks in a variety of circumstances. We discuss how this strategy improves public health and safety by providing an efficient manner of enforcing mask wearing standards. The report also discusses the obstacles, ethical concerns, and prospective applications of face mask detection systems in the ongoing fight against the pandemic. Dilip Kumar Sharma | Aaditya Yadav "DeepMask: Transforming Face Mask Identification for Better Pandemic Control in the COVID-19 Era" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64522.pdf Paper Url: https://www.ijtsrd.com/engineering/electronics-and-communication-engineering/64522/deepmask-transforming-face-mask-identification-for-better-pandemic-control-in-the-covid19-era/dilip-kumar-sharma
Streamlining Data Collection eCRF Design and Machine Learningijtsrd
Efficient and accurate data collection is paramount in clinical trials, and the design of Electronic Case Report Forms eCRFs plays a pivotal role in streamlining this process. This paper explores the integration of machine learning techniques in the design and implementation of eCRFs to enhance data collection efficiency. We delve into the synergies between eCRF design principles and machine learning algorithms, aiming to optimize data quality, reduce errors, and expedite the overall data collection process. The application of machine learning in eCRF design brings forth innovative approaches to data validation, anomaly detection, and real time adaptability. This paper discusses the benefits, challenges, and future prospects of leveraging machine learning in eCRF design for streamlined and advanced data collection in clinical trials. Dhanalakshmi D | Vijaya Lakshmi Kannareddy "Streamlining Data Collection: eCRF Design and Machine Learning" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63515.pdf Paper Url: https://www.ijtsrd.com/biological-science/biotechnology/63515/streamlining-data-collection-ecrf-design-and-machine-learning/dhanalakshmi-d
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
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The Art Pastor's Guide to Sabbath | Steve ThomasonSteve Thomason
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This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
2. International Journal of Trend in Scientific Research and Development @ www.ijtsrd.com eISSN: 2456-6470
@ IJTSRD | Unique Paper ID – IJTSRD52165 | Volume – 6 | Issue – 6 | September-October 2022 Page 1859
Structure of Dapagliflozin and Pioglitazone
hydrochloride were shown in Figure 1.
For the simultaneous determination of DAPA and
PIO, several analytical techniques have been
published for single drugs but not for this
combination. UV spectrophotometric methods [7-11]
and HPLC [12-20] were among the methods used.
Analytical method validation ensures that different
HPLC analytical procedures provide consistent and
repeatable results; it is a crucial stage in the
development of a method from a synthetic mixture
since it provides information on precision, linearity,
detection, and quantitation limits. "The goal of
validation of an analytical method is to demonstrate
that it is suitable for its intended purpose," according
to ICH standards. Validation data must now be
provided to the appropriate authorities during the
pharmaceutical development process. The ICH has
validation requirements for analytical procedures
[21].
This study developed a new sensitive and quick RP-
HPLC technique for identifying Dapagliflozin and
Pioglitazone hydrochloride in a synthetic mixture,
which was then validated as per ICH Q2 (R1)
regulations. The ICH Q1A (R2) recommendations
were used to conduct forced degradation tests in
which a synthetic mixture was subjected to acid, base,
oxidation, heat, and photolysis stress conditions [22].
2. Materials and Methods [23]
2.1. Instrumentation
A Systronics LC-138 device with a pump, Hamilton
sampler injector, column compartment, and UV
detector was used to conduct the HPLC analysis. To
collect and process all chromatographic data, Clarify
Software was used as a data acquisition tool.
2.2. Chromatographic Condition
The separation was performed using a Kromstar
Vertex C18 column (250 ×4.6 mm, 5µm). A mobile
phase of Methanol: 10mM potassium dihydrogen
phosphate buffer with 10% OPA pH 4.0 (25:75,v/v)
was used to equilibrate the column. Orthophosphoric
acid was used to adjust the buffer's final pH to 4.0.
The UV detector was set to 228nm, the injection
volume was 10 liters, the temperature was 30 ° C, and
the flow rate was 1 mL/min.
2.3. Chemicals and Reagents
Dapagliflozin standard and API were gifted from
Alembic Pharmaceuticals Pvt. Ltd, India.
Pioglitazone Hydrochloride standard and API were
gifted by Cadila Pharmaceuticals Pvt. Ltd, India.
Orthophosphoric acid (AR grade) was purchased
from Astron Chemical India, while Potassium
Dihydrogen Phosphate Buffer (AR Grade) was
purchased from Chemdyes Corporation in Rajkot,
India. Hydrogen Peroxide was delivered by LOBA
Chemie Pvt. Ltd of Mumbai, India. Acetonitrile and
Hydrochloric acid, both HPLC grade solvents, were
delivered by Merck Life Science Pvt. Ltd of Mumbai,
India. The remaining reagents were of analytical
grade.
2.4. Preparation of Solutions
2.4.1. Preparation of Buffer (10mM KH2PO4)
1.36 g of potassium dihydrogen hydrogen phosphate
(KH2PO4) was accurately weighed and transferred to
1000 mL water, dissolved in HPLC grade water,
sonicated for 10 minutes, and diluted with HPLC
grade Milli Q water. It was filtered through a 0.45µm
membrane filter.
2.4.2. Preparation of 10% Ortho-Phosphoric acid
10% Orthophosphoric acid was prepared by diluting
1.0 mL of concentrated OPA in 10 ml HPLC grade
water.
2.4.3. Preparation of Sodium hydroxide solution
(0.1 N)
Accurately weighed 4.0 gm of Sodium hydroxide was
transferred in a 100mL volumetric flask and diluted
with methanol up to 100 mL. From this solution take
a 10 mL aliquot and transferred it to a 100 mL
volumetric flask and diluted up to 100 mL with
methanol.
2.4.4. Preparation of Hydrochloric acid solution
(0.1 N)
0.86 ml Concentrated HCl transferred in 100 mL
volumetric flask and dilute with methanol up to 100
mL.
2.4.5. Preparation of Hydrogen peroxide solution
(3%)
From 30 % Hydrogen peroxide (H2O2) 10 mL was
transferred to a 100 mL volumetric flask and diluted
with methanol up to 100 mL.
2.4.6. Preparation of Mobile phase
A mixture of 10 mM Phosphate Buffer (pH 4.0
adjusts with 10% OPA): Methanol (75:25 % v/v)
Mobile phase was used after filtering it through a0.45
µm membrane filter and sonication.
2.4.7. Preparation of standard solutions
2.4.7.1. Preparation of standard stock solution of
Dapagliflozin (100 µg/mL)
Accurately weigh 10 mg of Dapagliflozin was
transferred into a 100 mL volumetric flask and
diluted with Methanol
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2.4.7.2. Preparation of standard stock solution of
Pioglitazone hydrochloride (100µg/mL)
Accurately weighing 10 mg of Pioglitazone
hydrochloride was transferred into a 100 mL
volumetric flask and diluted with Methanol.
2.5. Preparation of Calibration Curve
Analyses of standard solutions in the ranges of 2-10
µg/mL and 3-15 µg/mL were used to determine the
linearity of Dapagliflozin and Pioglitazone
hydrochloride. Pipette out 0.2, 0.4, 0.6, 0.8, and 1.0
mL solutions from the Stock solution of
Dapagliflozin (100 µg/mL) and 0.3, 0.6, 0.9, 1.2, and
1.5 mL solutions from the Stock solution of
Pioglitazone HCl (100 µg/mL) into a 10 mL
volumetric flask and make up with mobile phase to
obtain 2, 4, 6, 8, and 10 µg/mL for Dapagliflozin and
3, 6, 9, 12 and 15 µg/mL for Pioglitazone
hydrochloride, respectively.
2.6. Preparation of Sample Solution
Equivalent concentrations of Dapagliflozin (10 mg)
and Pioglitazone hydrochloride (15 mg) were
accurately weighed and transferred to a 100 mL
volumetric flask, where they were sonicated and
made up to the mark with methanol. Whatman filter
paper was used to filter this solution. Methanol was
used to dilute the filtrate to the desired concentration.
It has 100 µg/mL Dapagliflozin and 150 µg/mL
Pioglitazone hydrochloride. Pipette 0.4 ml solution
from Dapagliflozin (100 µg/mL) and Pioglitazone
hydrochloride (150 µg/mL) into a 10 mL volumetric
flask, and adjust the volume with the mobile phase to
the desired level. Dapagliflozin had a final
concentration of 4 µg/mL, while Pioglitazone
hydrochloride had a concentration of 6 µg/mL.
2.7. Preparation of Synthetic Mixture of
Dapagliflozin and Pioglitazone
Hydrochloride
The Dapagliflozin and Pioglitazone Hydrochloride
Synthetic Mixture were prepared in a 10:15 ratio.
PVP, Microcrystalline Cellulose, Lactose,
Magnesium Stearate, Talc, and the drugs
Dapagliflozin 10 mg and Pioglitazone Hydrochloride
15 mg are all frequent excipients. Equivalent weights
of Dapagliflozin (10 mg) and Pioglitazone
Hydrochloride (15 mg) were accurately weighed and
transferred to a 100 mL volumetric flask, where
Methanol was used to make up the half mark. This
solution was sonicated until the medication
disintegrated and then Methanol was added to get it
up to the correct concentration. The solution was then
filtered using Whatman filter paper. Dapagliflozin
was obtained at a concentration of 100 µg/mL, while
Pioglitazone Hydrochloride was obtained at a
concentration of 150 µg/mL. From the stock solution
of the synthetic mixture (Dapagliflozin is 100 µg/mL
and Pioglitazone Hydrochloride 150 µg/mL) pipette
out 0.4 mL and transferred into a volumetric flask of
10 mL and make up the volume with optimized
mobile phase,to get the concentration of 4 µg/mL and
6 µg/mL for Dapagliflozin and Pioglitazone
Hydrochloride respectively.20 µL of the above
solution was injected to perform the assay and %
RSD should be calculated.
2.8. Method Validation
The method was validated according to ICH
regulations ICH Q2 (R1), with validation parameters
such as specificity, linearity, range, accuracy,
precision, LOQ, LOD, and robustness [21].
2.9. Forced degradation studies
A synthetic mixture of Dapagliflozin 4 µg/mL and
Pioglitazone hydrochloride 6 µg/mL was stressed
under various conditions to conduct forced
degradation tests to establish whether the analytical
method and assay were stability-indicating. Methanol:
10 mM Potassium Dihydrogen Phosphate Buffer (pH
4.0) (25: 75 % v/v) was utilized as a solvent in all
experiments, and the solution of Dapagliflozin and
Pioglitazone hydrochloride was prepared in methanol.
All forced degradation solutions were prepared with
an initial concentration of 4µg/mL Dapagliflozin and
6 µg/mL Pioglitazone hydrochloride in a mixture
solution.
2.9.1. Acid degradation
Pipette 1 mL of sample solution from the mixed
solution into a 10 mL volumetric flask with precision.
Fill each flask with 1 mL of 0.1 N hydrochloric acid.
Keep the flask at 40 °C. for 2 hours. Remove the flask
from the water bath and chill the contents at 1 and 2-
hour intervals. Fill each flask with 1 mL of 0.1 N
sodium hydroxide. The mobile phase should be
diluted up to volume and mixed properly. Prepare a
blank preparation without a sample at the same time.
2.9.2. Base degradation
Pipette 1 mL of sample solution from the mixed
solution into a 10 mL volumetric flask with precision.
Fill each flask with 1 mL of 0.1 N sodium hydroxide.
Keep the flask at 40 ° C. for 2 hours. Remove the
flask from the water bath and cool the contents at 1
and 2-hour intervals. Fill each flask with 1 mL of 0.1
N hydrochloric acid. With the mobile Phase, dilute to
volume and mix properly. Prepare a blank preparation
without a sample at the same time.
2.9.3. Oxidation degradation
Pipette 1 mL of sample solution from the mixed
solution into a 10 mL volumetric flask with precision.
Fill each flask with 1 mL of 3 % hydrogen peroxide.
Keep the flask at 40 ° C. for 2 hours. Remove the
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flask from the water bath and cool the contents at 1
and 2-hour intervals. With the mobile phase, dilute to
volume and mix evenly. Prepare a blank preparation
without a sample at the same time.
2.9.4. Photolytic degradation
Drugs were placed in a photostability chamber and
exposed to direct UV light for two hours to assess
their photostability. Following removal from the
photostability chamber at 1 and 2-hour intervals, the
sample was prepared for analysis as previously
reported. Prepare a blank preparation without a
sample at the same time.
2.9.5. Thermal degradation
Pipette 1 mL of sample solution from the mixed
solution into a 10 mL volumetric flask with precision.
For 2 hours, it was exposed to heat at 80 °C. Remove
the flask from the water bath and cool the contents at
1 and 2-hour intervals. Add about 5 mL of methanol
and sonicate to completely dissolve it and bring the
volume up to the desired level with the mobile phase.
3. Result and Discussion [24]
3.1. Optimization of Chromatographic
Conditions
Different chromatographic conditions were used to
develop a suitable RP-HPLC method for
simultaneous estimation of Dapagliflozin and
Pioglitazone hydrochloride, and optimized
chromatographic conditions were developed shown in
Figures 2(a) and 2(b) respectively.
Chromatographic conditions for optimized mobile
phase trials
Column: Kromstar Vertex C18 (250 ×4.6 mm, 5µm)
Mobile Phase: 10 mM Potassium Dihydrogen
Phosphate Buffer (pH 4.0): Methanol (75:25 %v/v)
Detector: UV detector
Flow rate: 1 mL/min
Injection volume: 20 µL
Detection wavelength: 228 nm
Syringe: Hamilton
3.2. Specificity
For Dapagliflozin and Pioglitazone hydrochloride, the
specificity of the established analytical approach was
tested. To ensure that no contaminants influenced the
results, a placebo solution was placed onto a C18
column.
3.3. System Suitability Parameter
For System Suitability, the theoretical plates, tailing
factor, resolution, peak asymmetry, and % RSD for
peak area were considered. The results for DAPA and
PIO were evaluated using a specified chromatogram
and acceptance criteria. After injecting a stock
solution comprising a mixture of (4 g/mL) DAPA
and (6 g/mL) PIO three times, the chromatograms
were recorded. The number of theoretical plates,
resolution, and peak asymmetry were determined to
see if the result reached the suggested limit described
in Table 1.
3.4. Linearity of Dapagliflozin and Pioglitazone
HCl
The Linearity of Dapagliflozin and Pioglitazone HCl
were taken to be in the range of 2 –10 µg/mL and 3 –
15 µg/mL respectively. The Overlay Chromatogram
of Dapagliflozin and Pioglitazone HCl showed in
Figure 2(c). The % RSD of Dapagliflozin and
Pioglitazone HCl at 228 nm was found to be 0.16–
1.23 and 0.15 -1.17 respectively. The correlation
coefficient values for Dapagliflozin and Pioglitazone
HCl were found to be 0.996 and 0.998 respectively.
The regression line equation for Dapagliflozin and
Pioglitazone HCl were found to be y = 32.785x -
38.192 and y = 61.134x - 23.013. The results of
Linearity for Dapagliflozin and Pioglitazone HCl
showed in Table 1. The calibration Curve of
Dapagliflozin and Pioglitazone HCl showed in
Figures 2(d) and 2(e) respectively.
3.5. LOD and LOQ of Dapagliflozin and
Pioglitazone HCl
The LOD and LOQ of Dapagliflozin at 228 were
found to be 0.041 µg/mL and 0.13 µg/mL
respectively. The LOD and LOQ of Pioglitazone HCl
at 228 were found to be 0.105 µg/mL and 0.34
µg/mL respectively. All the results of LOD and LOQ
were shown in Table 1.
3.6. Precision of Dapagliflozin and Pioglitazone
HCl
The % RSD of Dapagliflozin and Pioglitazone HCl
for Intraday precision at 228nm was found to be 0.45
– 1.16 and 0.39 – 1.11, respectively. The % RSD of
Dapagliflozin and Pioglitazone HCl for Intraday
precision at 228nm was found to be 0.55 – 1.31 and
0.49 – 1.29, respectively. The % RSD of
Dapagliflozin and Pioglitazone HCl for Intraday
precision at 228nm was found to be 0.81 and 0.72,
respectively. The precision of Dapagliflozin and
Pioglitazone HCl showed in Table 1.
3.7. Accuracy of Dapagliflozin and Pioglitazone
HCl
The % recovery of Dapagliflozin and Pioglitazone
HCl was found to be 98.52% – 99.90 % and 99.67%
– 99.94% respectively. The recoveryof Dapagliflozin
and Pioglitazone HCl showed in Table 1.
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3.8. Robustness of Dapagliflozin and Pioglitazone
HCl
With the change of (± 0.2 ml/min) in flow rate, (± 2
nm) in wavelength, and (± 2v/v) in mobile phase
ratio, we can observe the robustness. The % Assay
was found to be 98.62% – 97.37% for Dapagliflozin
and 97.25% – 99.75% for Pioglitazone HCl after
changing the inflow rate of the mobile phase
respectively. The % RSD was found to be 98.75% –
100.12% for Dapagliflozin and 98.75% – 100.25%
for Pioglitazone HCl after changing in detection
wavelength respectively. The % RSD was found to
be 97.75% – 99.75% for Dapagliflozin and 97.75%–
99.75% for Pioglitazone HClafter changing in mobile
phase ratio respectively. The robustness of
Dapagliflozin and Pioglitazone HCl showed in Table
1.
3.9. Analysis of Synthetic mixture by the
developed method
The % assay of Dapagliflozin and Pioglitazone HCl
was found to be 99.75% and 99.84%, respectively.
Analysis of the synthetic mixture showed in Table 1
and Figure 2(f).
3.10. Forced degradation study
3.10.1. Acid degradation
At 1-2 hours after heating the drug solution with 0.1
N hydrochloric acid at 40˚C for 2 hours,
Dapagliflozin and Pioglitazone HCl were degraded.
Figure 3(a) describes the blank chromatogram of the
mobile phase. After 2 hours, three more peaks of
degradation were observed described in Figures 3(b)
and 3(c), respectively. The results were summarized
in Table 2.
3.10.2. Base degradation
At 1-2 hours after heating the drug solution with 0.1
N Sodium Hydroxide at 40°C for 2 hours,
Dapagliflozin and Pioglitazone hydrochloride were
degraded. After 2 hours, three more peaks of
degradation were observed described in Figures 3(d)
and 3(e), respectively. The results were shown in
Table 2.
3.10.3. Oxidation degradation
After heating the drug solution with % hydrogen
peroxide at room temperature for 2 hours,
Dapagliflozin and Pioglitazone hydrochloride were
degraded. After 2 hours, three more peaks of
degradation were observed shown in Figures 3(f) and
3(g). The results were summarized in Table 2.
3.10.4. Photolytic degradation
When the drug solution was exposed to direct UV
light for 2 hours, degradation was observed in
Dapagliflozin and Pioglitazone hydrochloride. After 2
hours, two more peaks of degradation were described
in Figures 3(h) and 3(i), respectively. The results
were shown in Table 2.
3.10.5. Thermal degradation
At 1-2 hours after heating the drug solution at 80 °C
for 2 hours, Dapagliflozin degradation and
Pioglitazone hydrochloride degradation were
observed in the chromatogram. After 2 hours, two
more peaks of degradation were observed shown in
Figures 3(j) and 3(k), respectively. The results were
summarized in Table 2.
4. Conclusion
For routine analysis of Dapagliflozin and Pioglitazone
HCl, a simple, precise, accurate, and fast
simultaneous estimate approach has been devised and
validated. The developed approach is suggested for
regular and manufacturing standards analysis of the
combination of Dapagliflozin and Pioglitazone HCl.
A stability-indicating RP-HPLC technique was
devised and validated for the determination of
Dapagliflozin and Pioglitazone HCl in synthetic
combinations. All method validation parameters meet
the ICH Q2 (R1) guideline's acceptance criteria. As a
result, we can conclude that the procedure is
selective, linear, accurate, and accurate. As a result, it
can be used to routinely analyze Dapagliflozin and
Pioglitazone HCl in synthetic mixtures. There was no
indication of any degradation in the major peak, and
the results were found to be within acceptable limits.
As a result, the proposed stability-indicating RP-
HPLC assay method may be used to estimate
Dapagliflozin and Pioglitazone HCl in the synthetic
mixture.
Ethical approval
This article does not contain any studies with human
participants or animals performed by authors.
Funding sources
This research did not receive any specific grant from
funding agencies in the public, commercial, or not-
for-profit sectors.
Declaration of Conflict of Interest
All authors declare that they have no conflict of
interest.
Acknowledgments
Dr. Vishva Patel and Dr. Jitendra O. Bhangale
professors, of Smt. N. M. Padalia Pharmacy College,
Ahmedabad, Gujarat-382210, India, provided
invaluable assistance to the authors. Dr. Mehul Patel,
professor of Ramanbhai Patel College of Pharmacy,
Charusat, Changa-388-421, India, provided excellent
guidance and support to the authors.
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(a) (b)
Figure 1: Chemical Structure of Dapagliflozin (a) and Pioglitazone Hydrochloride (b)
(A)
(B)
(C)
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(D) (E)
(F)
Figure 2: Chromatograms of Dapagliflozin and Pioglitazone Hydrochloride
(a) RP-HPLC Chromatogram of Blank in Phosphate Buffer (pH 4. 0): Methanol (75: 25 %v/v) at 228 nm
(b) RP-HPLC Chromatogram of Dapagliflozin (4 µg/ml) and Pioglitazone HCl (6 µg/ml) in Phosphate Buffer
(pH 4. 0): Methanol (75: 25 %v/v) at 228 nm.
(c) Overlay Chromatogram of Dapagliflozin 2-10 (µg/ml) and Pioglitazone HCl (3-15 µg/ml) at 228 nm.
(d) Calibration Curve of Dapagliflozin (2 - 10 µg/ml) at 228 nm.
(e) Calibration Curve of Pioglitazone hydrochloride (3 - 15 µg/ml) at 228 nm.
(f) Chromatogram of Dapagliflozin and Pioglitazone HCl in Synthetic mixture.
(A)
(B)
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(C)
(D)
(E)
(F)
(G)
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(H)
(I)
(J)
(K)
Figure 3: Forced degradation studies of Dapagliflozin and Pioglitazone HCl from Synthetic mixture
(*) Degradant peak formed in Chromatogram
(a) RP-HPLC Chromatogram of Blank in Phosphate Buffer (pH 4. 0): Methanol (75: 25 %v/v) at 228 nm.
(b) RP-HPLC Chromatogram of Acid Degradation for Dapagliflozin (4 µg/ml) and Pioglitazone HCl (6 µg/ml)
Sample after 1 hour 228 nm.
(c) RP-HPLC Chromatogram of Acid Degradation for Dapagliflozin (4 µg/ml) and Pioglitazone HCl (6 µg/ml)
Sample after 2 hour 228 nm.
(d) RP-HPLC Chromatogram of Base Degradation for Dapagliflozin (4 µg/ml) and Pioglitazone HCl (6 µg/ml)
Sample after 1 hour 228 nm.
(e) RP-HPLC Chromatogram of Base Degradation for Dapagliflozin (4 µg/ml) and Pioglitazone HCl (6 µg/ml)
Sample after 2 hour 228 nm.
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(f) RP-HPLC Chromatogram of Oxidation Degradation for Dapagliflozin (4 µg/ml) and Pioglitazone HCl (6
µg/ml) Sample after 1 hour 228 nm.
(g) RP-HPLC Chromatogram of Oxidation Degradation for Dapagliflozin (4 µg/ml) and Pioglitazone HCl (6
µg/ml) Sample after 2 hour 228 nm.
(h) RP-HPLC Chromatogram of Photo Degradation for Dapagliflozin (4 µg/ml) and Pioglitazone HCl (6 µg/ml)
Sample after 1 hour 228 nm.
(i) RP-HPLC Chromatogram of Photo Degradation for Dapagliflozin (4 µg/ml) and Pioglitazone HCl (6 µg/ml)
Sample after 2 hour 228 nm.
(j) RP-HPLC Chromatogram of Thermal Degradation for Dapagliflozin (4 µg/ml) and Pioglitazone HCl (6
µg/ml) Sample after 1 hour 228 nm.
(k) RP-HPLC Chromatogram of Thermal Degradation for Dapagliflozin (4 µg/ml) and Pioglitazone HCl (6
µg/ml) Sample after 2 hour 228 nm.
Table 1: Summary results for analytical method validation
Parameters Results obtained for DAPA Results obtained for PIO
System suitability parameter
Retention time 3. 5 min 6. 0 min
Theoretical Plates 6099 12857
Tailing Factors 1. 206 1. 102
Flow Rate 1mL/min 1mL/min
Linearity and Range 2-10 µg/mL 3-15 µg/mL
Linearity equation Y = 32. 785x - 38. 192 Y = 61. 134x - 23. 013
Regression value 0. 996 0. 998
Slope 32. 785 61. 134
Intercept 38. 192 23. 013
LOD (µg/mL) 0. 041 0. 105
LOQ (µg/mL) 0. 13 0. 34
Precision (%RSD) (n=3)
Repeatability 0. 81 0. 71
Interday 0. 89 0. 81
Intraday 0. 82 0. 72
Accuracy (n=3)
80 % (% Recovery) 98. 52 99. 67
80 % (% RSD) 1. 45 0. 91
100% (% Recovery) 99. 63 99. 84
100% (% RSD) 1. 31 1. 02
120% (% Recovery) 99. 90 99. 94
120% (% RSD) 1. 13 0. 95
Robustness (% Assay ± SD) (n=3)
Change in Flow rate (1 mL ± 0. 2 mL/ min)
0. 8 mL/min 97. 37±4. 5166 97. 75±2. 3730
1. 0 mL/min 99. 87±4. 2691 99. 75±3. 5545
1. 2 mL/min 98. 62±6. 4770 97. 25±5. 0286
Change in Detection wavelength (228 nm ± 2 nm)
226 97. 5±6. 1268 97. 25±0. 9454
228 100. 12±6. 4267 100. 25±1. 5055
230 98. 75±7. 0256 98. 75±1. 3762
Change in Mobile Phase ratio (ACN: Phosphate buffer 75: 25 ± 2 % v/v)
73: 27 98. 12±2. 0784 97. 75±2. 1116
75: 25 99. 75±1. 9421 99. 75±2. 0552
77: 23 97. 75±2. 0143 98. 25±2. 1845
Analysis of Synthetic mixture (%
Assay±SD)(n=3)
99. 75±1. 0146 99. 84±1. 1042
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Table 2: Summary of forced degradation studies of Dapagliflozin and Pioglitazone HCl from
Synthetic mixture
Sr.
No
Degradation Type Degradation Condition
% Assay observed
for DAPA (n=3)
% Assay observed
for PIO (n=3)
1 Acid Hydrolysis
0. 1 N HCl after 1 hour , 40 ° C 14. 68 6. 36
0. 1 N HCl after 2 hour, 40 ° C 18. 66 13. 70
2 Alkaline Hydrolysis
0. 1 N NaOH after 1 hour, 40 ° C 16. 30 10. 31
0. 1 N NaOH after 2 hour, 40 ° C 19. 53 14. 50
3 Oxidative Stress
3% H2O2 after 1 hour 13. 31 9. 58
3% H2O2 after 2 hour 17. 89 13. 72
4 Photolytic Stress
Kept in UV light after 1 hour 9. 59 8. 33
Kept in UV light after 2 hour 15. 65 12. 16
5 Thermal Stress
80° C after 1 hour 8. 35 6. 81
80 °C after 2 hour 13. 65 10. 44
Declaration of Conflict of Interest
All authors declare that they have no conflict of interest.