A novel, simple and economic reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the estimation of Nelaribine in bulk and tablet dosage form with greater precision and accuracy. Separation was achieved on Cosmiscil C18 column (150X4.6mm i.d.,5-µm) in isocratic mode using Triflouro acetic acid PH-3.6 buffer and Acetonitrile in the ratio of 90:10(v/v) as mobile phase, pumped in to the column at flow rate of 1.0 mL min-1and the detection of eluent from the column was carried out using variable wavelength UV detector at 248 nm. The total run time was 15 min and the column was maintained at ambient temperature. The retention time of Nelaribine was 4.003 min. The standard curves were linear over the concentration range of 25-150 -µg/ml with R2 0.999 and the LOD and LOQ values for Nelaribine were 0.04 -µg/ml and 0.12 -µg/ml , respectively. The percentage recovery was found to be 101.76 “ 98.72 %, the % RSD was found to be 0.43. The percentage amount of a marketed tablet formulation of Nelaribine was found to be 101.2 %. The method was validated as per ICH guidelines. Validation studies demonstrated that the proposed RP-HPLC method is simple, specific, rapid, reliable and reproducible. Hence the proposed method can be applied for the routine quality control analysis of Nelaribine in bulk and tablet dosage forms. Mrs.P.D.Chaithanya Sudha | Prof.D.Gowri Sankar"Validated RP-HPLC Method for the Determination of Nelaribine in Bulk and Tablet Dosage Form" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-1 | Issue-4 , June 2017, URL: http://www.ijtsrd.com/papers/ijtsrd181.pdf http://www.ijtsrd.com/pharmacy/analytical-chemistry/181/validated-rp-hplc-method-for-the-determination-of-nelaribine-in-bulk-and-tablet-dosage-form/mrspdchaithanya-sudha
Stability indicating method development and validation for the estimation of ...SriramNagarajan18
Stability indicating method development and validation for the estimation of Doxorubicin by using RP-HPLC method in a bulk and pharmaceutical dosage form
Determination of Chloramphenicol in Bulk Drug and Pharmaceutical Dosage Forms...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
New RP HPLC method for the simultaneous estimation of rosuvastatin and aspiri...SriramNagarajan19
A simple and selective LC method is described for the determination of Rosuvastatin and Aspirin tablet dosage forms. Chromatographic separation was achieved on a C18 column using mobile phase consisting of A mixture of 60 volumes of 20mM Phosphate buffer pH 3.5: 20 volumes of Acetonitrile and 20 voulmes of Methanol. With detection of 232 nm. Linearity was observed in the range 12-28 µg /ml for Rosuvastatin (r2 =0.9977) and 90-210 µg /ml for Aspirin (r2 =0.9953) 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.
Analytical method development and validation for the estimation of aspirin an...SriramNagarajan19
A simple and selective LC method is described for the determination of Aspirin and Omeprazole in tablet dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a mixture of 30 volumes of ammonium acetate buffer, 40 volumes of acetonitrile and 30 volumes of Methanol with detection of 233 nm. Linearity was observed in the range 18-42 µg/ml for Aspirin (r2 =0.983) and 6-14 µg /ml for Omeprazole (r2 =0.970) 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.
Analytical Method Development and Validation of Dutasteride and Tamsulosin Hc...SriramNagarajan15
A simple,specific, sensitive,precise and reproducible Reverse Phase High Performance liquid Chromatography method has been developed for simultaneous estimation of Dutasteride and Tamsulosin Hcl. Dutasteride and Tamsulosin is Anti-hyperplasia and Anti-hypertensive drug.The determinationwas carried out byusingsymmetryC-18columnwith Methanol:0.1M Monobasic potassiumdihydrogenphosphate buffer(75:25) Adjusted the pH to 2.5 with Ortho phosporic acid as the mobile phase and with the detection wavelength of274 nmrespectively.The flow rate is 0.7 ml/min.TheRetentiontime of Dutasteride,Tamsulosin Hcl was 2.218 minand 6.599 min respectively.Linearityforthe Dutasteride and Tamsulosin Hcl were found inthe rangeof 25-75µgmand 20-60µgm respectively.The limitof quantificationforbothdrugs wasfound to be30,24µg respectively.The recoveries of Tamsulosin and Dutasteride were found to be inthe range of 99.81-99.90 %and98.00-102.00%, respectively. The proposed method was validated suitably and canbeused for routine analysis. The degradation studies indicated Dutasteride and Tamsulosin Hcl to besusceptible to neutralhydrolysis, while Dutasteride and Tamsulosin Hcl showed degradation inacid, H2O2,photolytic and inpresenceof UV radiation.The degradation productsof Dutasteride andTamsulosin Hcl inacidic and photolytic conditions were well resolved from the pure drug with significant differences in the irretention time values. This method can be successfully employed forsimultaneous quantitative analysis of Dutasteride and Tamsulosin Hcl in formulations.
Stability indicating method development and validation for the estimation of ...SriramNagarajan18
Stability indicating method development and validation for the estimation of Doxorubicin by using RP-HPLC method in a bulk and pharmaceutical dosage form
Determination of Chloramphenicol in Bulk Drug and Pharmaceutical Dosage Forms...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
New RP HPLC method for the simultaneous estimation of rosuvastatin and aspiri...SriramNagarajan19
A simple and selective LC method is described for the determination of Rosuvastatin and Aspirin tablet dosage forms. Chromatographic separation was achieved on a C18 column using mobile phase consisting of A mixture of 60 volumes of 20mM Phosphate buffer pH 3.5: 20 volumes of Acetonitrile and 20 voulmes of Methanol. With detection of 232 nm. Linearity was observed in the range 12-28 µg /ml for Rosuvastatin (r2 =0.9977) and 90-210 µg /ml for Aspirin (r2 =0.9953) 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.
Analytical method development and validation for the estimation of aspirin an...SriramNagarajan19
A simple and selective LC method is described for the determination of Aspirin and Omeprazole in tablet dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a mixture of 30 volumes of ammonium acetate buffer, 40 volumes of acetonitrile and 30 volumes of Methanol with detection of 233 nm. Linearity was observed in the range 18-42 µg/ml for Aspirin (r2 =0.983) and 6-14 µg /ml for Omeprazole (r2 =0.970) 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.
Analytical Method Development and Validation of Dutasteride and Tamsulosin Hc...SriramNagarajan15
A simple,specific, sensitive,precise and reproducible Reverse Phase High Performance liquid Chromatography method has been developed for simultaneous estimation of Dutasteride and Tamsulosin Hcl. Dutasteride and Tamsulosin is Anti-hyperplasia and Anti-hypertensive drug.The determinationwas carried out byusingsymmetryC-18columnwith Methanol:0.1M Monobasic potassiumdihydrogenphosphate buffer(75:25) Adjusted the pH to 2.5 with Ortho phosporic acid as the mobile phase and with the detection wavelength of274 nmrespectively.The flow rate is 0.7 ml/min.TheRetentiontime of Dutasteride,Tamsulosin Hcl was 2.218 minand 6.599 min respectively.Linearityforthe Dutasteride and Tamsulosin Hcl were found inthe rangeof 25-75µgmand 20-60µgm respectively.The limitof quantificationforbothdrugs wasfound to be30,24µg respectively.The recoveries of Tamsulosin and Dutasteride were found to be inthe range of 99.81-99.90 %and98.00-102.00%, respectively. The proposed method was validated suitably and canbeused for routine analysis. The degradation studies indicated Dutasteride and Tamsulosin Hcl to besusceptible to neutralhydrolysis, while Dutasteride and Tamsulosin Hcl showed degradation inacid, H2O2,photolytic and inpresenceof UV radiation.The degradation productsof Dutasteride andTamsulosin Hcl inacidic and photolytic conditions were well resolved from the pure drug with significant differences in the irretention time values. This method can be successfully employed forsimultaneous quantitative analysis of Dutasteride and Tamsulosin Hcl in formulations.
Method Development and Validation of Naftopidil by Reverse Phase-HPLC in Bulk...SriramNagarajan15
A new simple, accurate, rapid and precise isocratic High performance liquid chromatographic (HPLC) method was developed and validated for the determination of Etomidate (ETO) injection. The Method employs Waters HPLC system on Develosil –ods-UG column (300 x 3.9 mm x 5µm) and flow rate of 1.5 mL/min with a load of 20 µL. Acetonitrile and Phosphate buffer was used as mobile phase in the composition of 40:60. The Detection was carried out at 254 nm. Linearity ranges for Etomidate was 40-240 µg/ml respectively. Retention Time of Etomidate was found to be 12.061 minutes respectively. Percent recovery study values of Etomidate were found to be within 98-102 %. This newly developed method was successfully utilized for the Quantitative estimation of Etomidate in injectables. This method was validated for accuracy, precision, linearity and Robustness as per ICH guidelines.
New spectrophotometric methods for the quantitative estimation of oxolamine i...IJSIT Editor
Five simple, sensitive and economical spectrophotometric methods have been developed for the
determination of Oxolamine in commercial dosage forms. The methods were based on the formation of
colored complex of Oxolamine with different reagents. The absorbance of the formed color complex is
measured at the wavelength of maximum absorbance of the complex against the reagent blank treated
similarly. All these method have different linearity ranges. Statistical analysis proves that the proposed
methods are reproducible and selective for the estimation of Oxolamine in bulk drug and in its tablet dosage
form.
Kinetic Spectrophotometric Determination of Drugs Based On Oxidation by Alkal...IOSR Journals
Simple, accurate and precise spectrophotometic methods for quantitative determination of four drugs viz., Levofloxacin (LEV), Moxifloxacin (MOX), Pseudo Ephidrine (PSE), Torsemide (TOR) have been developed based on oxidation of the drugs by alk.KMnO4. Kinetics of the oxidation reaction is followed spectrophotometrically, as one of the reaction product, Mn(VI), absorbed at 610 nm. Initial rate and fixed time method are used for the construction of calibration curves Beer’s law is obeyed in the range 6.25-37.5 μg ml-1 for LEV; 5-30 μg ml-1 for MOX; 6.25-37.5 μg ml-1 for PSE and 2.5-15 μg ml-1 for TOR. Recovery studies using pure samples and pharmulations in the Beer’s Law limits have been carried out. Excellent recoveries indicate the methods are accurate and precise. The methods have been validated in terms of ICH guidelines. Statistical analysis in terms of student’s t- test and variance F- tests demonstrate high accuracy and precision and suggest the methods can be applied in bulk drug and pharmaceutical industries.
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.
Multiple Method Development and Validation for Simultaneous Estimation of Chl...ijtsrd
A simple, precise and accurate multiple analytical method has been developed for the simultaneous estimation of Chlorzoxazone and Nimesulide in bulk and tablet formulations by reversed-phase liquid chromatographic and UV-Visible spectrophotometric techniques. The chromatographic separation was achieved on C18 analytical column. A mixture of Methanol 0.1 Ortho-phosphoric acid 75 25 was used as mobile phase, at a flow rate of 1mL min and detection wavelength at 295 nm. The retention time of Chlorzoxazone and Nimesulide was found to be 4.69 and 5.45 min respectively. The linear dynamic ranges for HPLC were from 2-10 µg mL and for simultaneous equation method, derivative spectroscopy, Q-ratio Absorbance method, Dual wavelength it was 10-30 µg mL for both Chlorzoxazone and Nimesulide. The percentage recovery obtained for Chlorzoxazone and Nimesulide were 100.93 and 102.19 respectively for RP-HPLC, 9.7 and 100.1 for simultaneous equation method of CZ and NIM respectively, 99.97 and 99.78 for derivative spectroscopy of CZ and NIM respectively, 101.37 and 99.48 for Q-ratio Absorbance method of CZ and NIM respectively, 100.13 and 99.96 for dual wavelength method of CZ and NIM respectively. The validation of the proposed methods were carried out for linearity, accuracy, precision, limit of detection, limit of quantitation and robustness. The developed method can be used for routine quality control analysis of titled drugs in combination in tablet formulation. Swetha Yarramsetti | A. Elphine Prabahar | Rama Rao Nadendla "Multiple Method Development and Validation for Simultaneous Estimation of Chlorzoxazone and Nimesulide in Bulk and Pharmaceutical Dosage Form" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-2 , February 2019, URL: https://www.ijtsrd.com/papers/ijtsrd21503.pdf
Paper URL: https://www.ijtsrd.com/pharmacy/analytical-chemistry/21503/multiple-method-development-and-validation-for--simultaneous-estimation-of-chlorzoxazone-and--nimesulide-in-bulk-and-pharmaceutical-dosage-form/swetha-yarramsetti
Physiology and Biochemistry-I (Marks-25)
a) Hematology
i) Study of compound microscope ii) Microscopically study of blood cells iii) Different types of WBC, erythrocytes and platelets iv) Examination of hemoglobin v) Differential count of WBC vi) Total count of RBC and WBC vii) Determination of clotting and bleeding time viii) Examination of clot under the microscope ix) Effect of chemical agents of RBC x) Fragility test of RBC. xi) Determination of erythrocytes sedimentation rate xii) Examination of haemin crystals
b) Histology: Histology of muscle, liver, spleen, stomach, duodenum, pancreas, lung, kidney, skin and endocrine glands.
c)Chemical physiology:
i) Qualitative test of carbohydrates, proteins and fats ii) Qualitative and quantitative experiments on digestive juice. iii) Examination of urine, estimation of main constituents and detection of abnormal constituents.
A new analytical method development and validation for the simultaneus estima...SriramNagarajan19
A simple and selective LC method is described for the determination of Albuterol and Ipratropium Bromide in tablet dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a mixture of 80 volumes of methanol and 20 volumes of water with detection of 239 nm. Linearity was observed in the range 36-84 µg /ml for Albuterol (r2 =0.996) and 6-14 µg /ml for Ipratropium Bromide (r2 =0.997) 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.
Method Development and Validation of Naftopidil by Reverse Phase-HPLC in Bulk...SriramNagarajan15
A new simple, accurate, rapid and precise isocratic High performance liquid chromatographic (HPLC) method was developed and validated for the determination of Etomidate (ETO) injection. The Method employs Waters HPLC system on Develosil –ods-UG column (300 x 3.9 mm x 5µm) and flow rate of 1.5 mL/min with a load of 20 µL. Acetonitrile and Phosphate buffer was used as mobile phase in the composition of 40:60. The Detection was carried out at 254 nm. Linearity ranges for Etomidate was 40-240 µg/ml respectively. Retention Time of Etomidate was found to be 12.061 minutes respectively. Percent recovery study values of Etomidate were found to be within 98-102 %. This newly developed method was successfully utilized for the Quantitative estimation of Etomidate in injectables. This method was validated for accuracy, precision, linearity and Robustness as per ICH guidelines.
New spectrophotometric methods for the quantitative estimation of oxolamine i...IJSIT Editor
Five simple, sensitive and economical spectrophotometric methods have been developed for the
determination of Oxolamine in commercial dosage forms. The methods were based on the formation of
colored complex of Oxolamine with different reagents. The absorbance of the formed color complex is
measured at the wavelength of maximum absorbance of the complex against the reagent blank treated
similarly. All these method have different linearity ranges. Statistical analysis proves that the proposed
methods are reproducible and selective for the estimation of Oxolamine in bulk drug and in its tablet dosage
form.
Kinetic Spectrophotometric Determination of Drugs Based On Oxidation by Alkal...IOSR Journals
Simple, accurate and precise spectrophotometic methods for quantitative determination of four drugs viz., Levofloxacin (LEV), Moxifloxacin (MOX), Pseudo Ephidrine (PSE), Torsemide (TOR) have been developed based on oxidation of the drugs by alk.KMnO4. Kinetics of the oxidation reaction is followed spectrophotometrically, as one of the reaction product, Mn(VI), absorbed at 610 nm. Initial rate and fixed time method are used for the construction of calibration curves Beer’s law is obeyed in the range 6.25-37.5 μg ml-1 for LEV; 5-30 μg ml-1 for MOX; 6.25-37.5 μg ml-1 for PSE and 2.5-15 μg ml-1 for TOR. Recovery studies using pure samples and pharmulations in the Beer’s Law limits have been carried out. Excellent recoveries indicate the methods are accurate and precise. The methods have been validated in terms of ICH guidelines. Statistical analysis in terms of student’s t- test and variance F- tests demonstrate high accuracy and precision and suggest the methods can be applied in bulk drug and pharmaceutical industries.
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.
Multiple Method Development and Validation for Simultaneous Estimation of Chl...ijtsrd
A simple, precise and accurate multiple analytical method has been developed for the simultaneous estimation of Chlorzoxazone and Nimesulide in bulk and tablet formulations by reversed-phase liquid chromatographic and UV-Visible spectrophotometric techniques. The chromatographic separation was achieved on C18 analytical column. A mixture of Methanol 0.1 Ortho-phosphoric acid 75 25 was used as mobile phase, at a flow rate of 1mL min and detection wavelength at 295 nm. The retention time of Chlorzoxazone and Nimesulide was found to be 4.69 and 5.45 min respectively. The linear dynamic ranges for HPLC were from 2-10 µg mL and for simultaneous equation method, derivative spectroscopy, Q-ratio Absorbance method, Dual wavelength it was 10-30 µg mL for both Chlorzoxazone and Nimesulide. The percentage recovery obtained for Chlorzoxazone and Nimesulide were 100.93 and 102.19 respectively for RP-HPLC, 9.7 and 100.1 for simultaneous equation method of CZ and NIM respectively, 99.97 and 99.78 for derivative spectroscopy of CZ and NIM respectively, 101.37 and 99.48 for Q-ratio Absorbance method of CZ and NIM respectively, 100.13 and 99.96 for dual wavelength method of CZ and NIM respectively. The validation of the proposed methods were carried out for linearity, accuracy, precision, limit of detection, limit of quantitation and robustness. The developed method can be used for routine quality control analysis of titled drugs in combination in tablet formulation. Swetha Yarramsetti | A. Elphine Prabahar | Rama Rao Nadendla "Multiple Method Development and Validation for Simultaneous Estimation of Chlorzoxazone and Nimesulide in Bulk and Pharmaceutical Dosage Form" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-2 , February 2019, URL: https://www.ijtsrd.com/papers/ijtsrd21503.pdf
Paper URL: https://www.ijtsrd.com/pharmacy/analytical-chemistry/21503/multiple-method-development-and-validation-for--simultaneous-estimation-of-chlorzoxazone-and--nimesulide-in-bulk-and-pharmaceutical-dosage-form/swetha-yarramsetti
Physiology and Biochemistry-I (Marks-25)
a) Hematology
i) Study of compound microscope ii) Microscopically study of blood cells iii) Different types of WBC, erythrocytes and platelets iv) Examination of hemoglobin v) Differential count of WBC vi) Total count of RBC and WBC vii) Determination of clotting and bleeding time viii) Examination of clot under the microscope ix) Effect of chemical agents of RBC x) Fragility test of RBC. xi) Determination of erythrocytes sedimentation rate xii) Examination of haemin crystals
b) Histology: Histology of muscle, liver, spleen, stomach, duodenum, pancreas, lung, kidney, skin and endocrine glands.
c)Chemical physiology:
i) Qualitative test of carbohydrates, proteins and fats ii) Qualitative and quantitative experiments on digestive juice. iii) Examination of urine, estimation of main constituents and detection of abnormal constituents.
A new analytical method development and validation for the simultaneus estima...SriramNagarajan19
A simple and selective LC method is described for the determination of Albuterol and Ipratropium Bromide in tablet dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a mixture of 80 volumes of methanol and 20 volumes of water with detection of 239 nm. Linearity was observed in the range 36-84 µg /ml for Albuterol (r2 =0.996) and 6-14 µg /ml for Ipratropium Bromide (r2 =0.997) 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.
A new analytical method development and validation for the estimation of lenv...SriramNagarajan19
A simple and selective LC method is described for the determination of Lenvatinib dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a mixture of Phosphate buffer (KH2PO4): Acetonitrile (80:20) with detection of 240nm. Linearity was observed in the range 60-140 µg /ml for Lenvatinib (r2 =0.996) for the amount of drug 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.
Method Development and Validation of Naftopidil by Reverse Phase-HPLC in Bulk...SriramNagarajan15
A new simple, accurate, rapid and precise isocratic High performance liquid chromatographic (HPLC) method was developed and validated for the determination of Etomidate (ETO) injection. The Method employs Waters HPLC system on Develosil –ods-UG column (300 x 3.9 mm x 5µm) and flow rate of 1.5 mL/min with a load of 20 µL. Acetonitrile and Phosphate buffer was used as mobile phase in the composition of 40:60. The Detection was carried out at 254 nm. Linearity ranges for Etomidate was 40-240 µg/ml respectively. Retention Time of Etomidate was found to be 12.061 minutes respectively. Percent recovery study values of Etomidate were found to be within 98-102 %. This newly developed method was successfully utilized for the Quantitative estimation of Etomidate in injectables. This method was validated for accuracy, precision, linearity and Robustness as per ICH guidelines.
International Journal of Pharmaceutical Science Invention (IJPSI) is an international journal intended for professionals and researchers in all fields of Pahrmaceutical Science. IJPSI publishes research articles and reviews within the whole field Pharmacy and Pharmaceutical Science, new teaching methods, assessment, validation and the impact of new technologies and it will continue to provide information on the latest trends and developments in this ever-expanding subject. The publications of papers are selected through double peer reviewed to ensure originality, relevance, and readability. The articles published in our journal can be accessed online.
Analytical Method Development and Validation for the Estimation of Related Su...BRNSS Publication Hub
Reverse-phase high-performance liquid chromatographic method has been developed for the determination
of related compound of oxybutynin hydrochloride in pure form and pharmaceutical dosage forms.
Isocratic elution at a flow rate of 1.0 ml/min was employed on a primesil-C18 column (150 × 4.6 mm,
3.5 μm SS) at 45°C. The mobile phase consisted of mixture of water:acetonitrile:triethylamine in the
ratio of 690:310:2 (%V/V), respectively, and the ultraviolet detection wavelength was 210 nm. The RT
value of oxybutynin hydrochloride, impurity-D, and impurity-A was found to be 13.75 min, 19.80 min,
and 24.89 min, respectively, with a run time of 60 min. The developed method was validated for linearity,
accuracy, precision, detection limit, quantification limit, robustness, specificity, and system suitability.
Results of all validation parameters were within the limits as per ICH guidelines.
A Simple Rp- HPLC Method for Simultaneous Estimation of Six Cardiovascular Dr...iosrjce
A simple, convenient Rp-HPLC method has been developed and validated for the simultaneous
estimation of Metolazone, Indapamide, Nebivolol, Rosuvastatin, Olmesartan and Spironolactone. The column
used was an Inertsil ODS 3 V column of 250 mm length × 4.6 mm ID, with 3 micron particle size of adsorbent.
Separation was achieved using isocratic elution in a buffer-acetonitrile-methanol mobile phase at a flow rate of
1.2 ml/min. The detection was performed at wavelength of 225 nm using a UV detector. The column temperature
was 450C and injection volume was 20µl. The method was validated for precision, linearity and accuracy. The
% RSD for all the drugs was found to be less than 2 %. The correlation coefficient (r2
) was not less than 0.999
for all drugs. The mean percent recovery of the drugs from tablet placebo at 50%, 100% and 150% were within
limits. The marketed formulations of the drugs were analyzed and the mean assay results were found to be
within limits. The developed method can thus be employed for routine simultaneous analysis of Metolazone,
Indapamide, Nebivolol, Rosuvastatin, Olmesartan and Spironolactone in bulk and in their marketed
formulations
Development and Validation of Reverse Phase Liquid Chromatography Method for ...IOSR Journals
A simple, precise and reversed phase liquid chromatographic method was developed and it is validated for estimation of losartan in bulk drug. Losartan is use for treatment of hypertension. The separation was achieved on Acquity BEH C18 1.7μ, (2.1 X 100) mm, analytical column with mobile phase consisted of buffer (adjust pH 3.0 of water with dilute formic acid) : Acetonitrile (50:50 v/v) at isocratic flow of 0.3ml/min with UV detection wavelength was at 230 nm. The method was successfully validated in accordance to ICH guidelines for accuracy, precision, specificity, linearity. The linear regression analysis data for calibration plots showed good linear relationship in the concentration range 25-75μg/mL for losartan. The % Recovery/Accuracy was within the range between 98% and 102%. The percentage RSD for precision method was found to be less than 2%. The method was successfully applied for routine analysis of losartan in bulk samples
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.
A new precise accurate and reliable validated method for the determination of Capecitabine was developed by using
reverse phase high performance liquid chromatography in pharmaceutical dosage forms. Spectrophotometer
determination was carried out at an absorption maximum of 240nm by using methanol. The linearity was over the
concentration range of 20-120 μg/ml with correlation coefficient 0.999. Chromatographic separation was carried
out by using a mobile phase of methanol: Acetonitrile: water (80:20:80 V/V) on Waters 2487 dual absorbance
column in an isocratic mode at a flow rate of 1.1 ml/min with UV detection at 240 nm. The developed methods were
found to be precise and accurate for the estimation of Capecitabine in pharmaceutical dosage forms and could be
used for routine analysis.
Keywords: Capecitabine, RP-HPLC, Spectrophotometry, Waters 2487 dual absorbance detector, Nova pack 300 ×
3.9mm 5μ as column, 240nm
RP-HPLC Assay Method Validation for the estimation of new Anti-retroviral dru...SriramNagarajan15
A Reverse phase HPLC method was developed for estimation of the Lamivudine in bulk and tablet formulation by using ODS column (250mm×4.6mm, 5µm) and Acetate buffer: acetonitrile (50:50) as mobile phase, at a flow rate of 1.5ml/min. The detection was carried at the 272nm the retention time of the Lamivudine is 1.850. The developed method was validated for the various parameters as per the ICH guidelines like accuracy precision, linearity and range, Robustnes. Linearity was obtained in the concentration range of 10µg/ml to 50µg/ml with correlation coefficient of 0.999. The accuracy of the method was assessed by recovery studies at three different concentration levels. The percentage recovery of Lamivudine was found to be in the range of 98% -102%. The method was found to be precise as indicated by the repeatability, inter-day, intra-day analysis, showing %RSD less than 2. Key words: RP-HPLC, Lamivudine, Pharmaceutical dosage form.
‘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
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Validated RP-HPLC Method for the Determination of Nelaribine in Bulk and Tablet Dosage Form
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Validated RP-HPLC Method for the Determination of
Nelaribine in Bulk and Tablet Dosage Form
Prof. D. Chaithanya Sudha
A.U. College of Pharmaceutical Sciences,
Andhra University, Visakhapatnam, A.P, India
Prof. D. Gowri Sankar
A.U. College of Pharmaceutical Sciences,
Andhra University, Visakhapatnam, A.P, India
ABSTRACT
A novel, simple and economic reverse phase high
performance liquid chromatography (RP-HPLC)
method has been developed for the estimation of
Nelaribine in bulk and tablet dosage form with greater
precision and accuracy. Separation was achieved on
Cosmiscil C18 column (150X4.6mm i.d.,5µm) in
isocratic mode using Triflouro acetic acid PH-3.6
buffer and Acetonitrile in the ratio of 90:10(v/v) as
mobile phase, pumped in to the column at flow rate of
1.0 mL min−1and the detection of eluent from the
column was carried out using variable wavelength UV
detector at 248 nm. The total run time was 15 min and
the column was maintained at ambient temperature.
The retention time of Nelaribine was 4.003 min. The
standard curves were linear over the concentration
range of 25-150 µg/ml with R2 0.999 and the LOD
and LOQ values for Nelaribine were 0.04 µg/ml and
0.12 µg/ml, respectively. The percentage recovery
was found to be 101.76 – 98.72 %, the % RSD was
found to be 0.43. The percentage amount of a
marketed tablet formulation of Nelaribine was found
to be 101.2 %. The method was validated as per ICH
guidelines. Validation studies demonstrated that the
proposed RP-HPLC method is simple, specific, rapid,
reliable and reproducible. Hence the proposed method
can be applied for the routine quality control analysis
of Nelaribine in bulk and tablet dosage forms.
KEYWORDS: Nelaribine, RP-HPLC, Method
Development, Validation, ICH guidelines
1. INTRODUCTION
NELARABINE is a purine nucleoside analog
converted to its corresponding arbinosylguanine
nucleoside tri phosphate results inhibition of DNA
synthesis and cytotoxicity. The drug is ultimately
metabolized into the active 51-tri phosphate ara –GTP
which disrupts the DNA synthesis and induces
apoptosis. Nelarabine is used to treat T-cell acute
Lymphoblastic leukemia and T-cell lymphoblastic
lymphoma. The Chemical name of Nelaribine
(2R,3S,4S,5R)-2-(2-amino-6-methoxy-9H-purin-9-
yl)-5 -(hydroxymethyl) oxolane-3,4-diol and chemical
formula is C10H11ClFN5O3 and molecular weight is
297.27 g/mol.
MATERIALS AND METHODS
Chemicals and solvents
The reference sample of NELARABINE was supplied
by M/s Natco laboratories,Hyd. The Branded
formulations of NELARABINE (Arranon Vials;
Glaxosmithkline) were purchased from the local
market. Ortho phosphoric acid, Acetonitrile, and
water used are of HPLC grade.
Instrumentation
A Aliance waters (2487) HPLC instrument, equipped
with a Cosmicsil Adza C-18 (150x4.6mm), 5µm, an
LC 20 AD pump and a SPD 20AD UV-Visible
detector was employed in this study.
Chromatographic analysis and data acquisition was
monitored by using empower-2software. A 20 μL
Hamilton injection syringe was employed for sample
injection. Degassing of the mobile phase was done by
using a SV scientific ultrasonic sonicator. A Mettle
Toledo AL 104 electronic balance was used for
weighing the materials. Class ‘A’ Borosil glass ware
(Borosil, India) was employed for volumetric and
general purpose in the entire study.
Chromatographic Conditions
The mobile phase consists of PH 3.6 buffer :
Acetonitrile in the ratio of 90:10 v/v%. The mobile
phase was pumped from solvent reservoir in the ratio
of 90:10 %v/v to the column in the flow rate of 1.0
ml/min whereas run time set was 15 min. The
separation was performed on Cosmicsil C18 column
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and the column was maintained the temperature of
25°C and the volume of each injection was 10 μL.
Prior to injection, the column was equilibrated for at
least 30 min with mobile phase flowing through the
system. The eluents were monitored at 248 nm.
Preparation of buffer solution: (PH: 3.6):
1ml of Trifloroacetic acid solution in a 1000ml of
volumetric flask add about 100ml of milli-Q water
and final volume make up to 1000 ml with milli-Q
water and degas to sonicate and finally make up the
volume with water then added 1ml of Triethylamine
then pH adjusted to 3.6with dil. Trifloroacetic acid
solution.
Preparation of mobile phase:
Buffer and Acetonitrile are in the ratio 90:10 %v/v,
filtered through 0.45 μ filter under vacuum.
Preparation of standard solution: (100µg/ml):
Accurately Weigh and transfer accurately 31.25 mg of
Nelarabine working Standard into a 50 ml clean dry
volumetric flask, and add about 30 ml of diluents,
dissolve and dilute to volume with diluents. Transfer
2.0 ml above solution into 200 ml volumetric flask
and dilute to volume with diluent( Milli-Q water as
diluent).
Preparation of sample solution:
Accurately pipette out 2.0 ml of sample solution in to
200 mL volumetric flask without any loss of solution.
Add 120 ml 0f diluent, shake well to dissolve and
dilute to volume with diluents and mix well. From the
filtered solution 1ml was pipette out into a 10 ml
volumetric flask and made up to 10ml with diluent.
Label Claim: 37.5 mg of Nelaribine
Validation of Proposed method:
The developed method was validated as per the ICH
(International Conference on Harmonization)
guidelines with respect to System suitability,
Precision, Specificity, Forced degradation studies,
Linearity, Accuracy, Limit of detection and Limit of
quantification.
Linearity
Aliquots of 0.25, 0.5, 0.75, 1.0, 1.25 and 1.5 ml were
taken from stock solution of concentration 100 µg/ml
of Nelaribine and then diluted up to mark with
diluent. Such that the final concentrations were in the
range 25-150 ppm of Nelaribine. Volume of 10μl of
each sample was injected in five times for each
concentration level and calibration curve was
constructed by plotting the peak area versus drug
concentration. A linear relationship between peakarea
vs. concentration was observed in the range of study.
The observations and calibration curve were shown in
figure.2.
Linearity and Construction of calibration curve
The quantitative determination of the drug was
accomplished by the external standard method. The
mobile phase was filtered through a 0.45μ membrane
filter before use. The flow rate of the mobile phase
was adjusted to 1.0 mL/min. The column was
equilibrated with the mobile phase for at least 30 min
prior to the injection of the drug solution. The column
temperature is maintained at 25±10 C throughout the
study. Linearity of the peak area response was
determined by taking six replicate measurements at
seven concentration points. Working dilutions of
NELARABINE in the range of 25-150 μg/mL were
prepared by taking suitable dilutions of the standard
solutions in different 10 mL volumetric flasks and
diluted up to the mark with the mobile phase. Twenty
microlitres of the dilutions was injected each time into
the column at flow rate of 1.0 mL/min. Each dilution
was injected six times into the column. The drug in
the eluents was monitored at 248 nm and the
corresponding chromatograms were obtained. From
the chromatograms, the mean peak areas were noted
and a plot of concentrations over the peak areas was
constructed. The regression of the plot was computed
by least squares method. The linear relationship was
found to be in the range of 25-150 μg / mL between
the concentration of NELARABINE and peak area
response. This regression equation was later used to
estimate the amount of NELARABINE in
pharmaceutical dosage forms. The linearity plot was
shown in the Fig.2 and the linearity data and the
statistical parameters for the linearity plot are reported
in Table 3 & 4.
VALIDATION OF THE PROPOSED METHOD:
The method was validated in compliance with ICH
guidelines. The following parameters were
determined for validation.
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Specificity
The method specificity was assessed by comparing
the chromatograms obtained from the drug with the
most commonly used excipient mixture with those
obtained from the blank solution. The blank solution
was prepared by mixing the excipients in the mobile
phase without the drug. The drug to excipient ratio
used was similar to that in the commercial
formulations. The commonly used excipients in
formulations like lactose, starch, microcrystalline
cellulose, ethyl cellulose, hydroxyl propyl
methylcellulose, magnesium stearate and colloidal
silicon dioxide were used for the study. The mixtures
were filtered through 0.45μ membrane filter before
injection. An observation of the chromatograms
indicates absence of excipient peaks near the drug
peak in the study runtime. This indicates that the
method is specific.
Precision
Precision is the degree of repeatability of an analytical
method under normal operational conditions. The
precision of the method was studied in terms of
repeatability (intra-day assay) and intermediate
precision (inter-day assay). Method repeatability was
studied by repeating the assay three times in the same
day for intra-day precision and intermediate precision
was studied by repeating the assay on three different
days, three times on each day (inter-day precision).
The intra-day and inter-day variation for
determination of NELARABINE was carried out at
three different concentration levels 25, 50, 75 μg/mL
level. The coefficient of variation values as presented
in the Table.5 shows that the method provides
acceptable (<2) intraday and inter-day variation.
Accuracy
Accuracy of the method was evaluated by standard
addition method. An amount of the pure drug at three
different concentration levels in its solution has been
added to the pre analysed working standard solution
of the drug. The sample solutions were analysed in
triplicate at each level as per the proposed method.
The percent individual recovery and %RSD for
recovery at each level are calculated. The results are
tabulated (Table.6). A recovery ranged from 98.72 –
102 % has been obtained by the method indicates its
accuracy.
Robustness
A study was conducted to determine the effect of
deliberate variations in the optimized
chromatographic conditions like composition of the
mobile phase, flow rate, and mobile phase pH. The
effect of these changes on the system suitability
parameters like tailing factor and number of
theoretical plates and on assay was studied. A single
condition was varied at a time keeping all other
parameters constant. The results were found to be
within the allowed limits which indicate that the
method is specific.
Variations in flow rate of the mobile phase:
Demonstrated robustness of method by changing the
flow rate for 0.9 ml/min and 1.1 ml/min instead of
specified flow rate (1.0 ml/min). By injecting the
replicate injections of standard in 0.9 ml/min and 1.1
ml/min flow rate and found that system suitability
parameters were passed. The %RSD of peak area,
tailing factor and theoretical plates of Nelarabine
standard was found within the limits.
Variations in the pH of the mobile phase:
The effect of variation in the pH of the mobile phase
was evaluated at ± 0.2 levels. The system suitability
results were found to be within the limits as shown in
the following table-
Variations in the temperature of column:
Robustness of the method by changing the column
temperature for 28°C and 31°C instead of specified
column temperature (30°C) are shown. By injecting
the replicate injections of standard in 28°C column
and 31°C column temperature and found that system
suitability parameters were passed. The %RSD of
peak area, tailing factor and theoretical plates of
Nelarabine standard was found within the limits.
Limit of Detection and Limit of Quantification
Limit of detection (LOD) is defined as the lowest
concentration of analyte that gives a measurable
response. LOD is determined based on signal to noise
ratio (S/N) of three times typically for HPLC
methods. The limit of quantification (LOQ) is defined
as the lowest concentration that can be quantified
reliably with a specified level of accuracy and
precision. It is the lowest concentration at which the
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precision expressed by a RSD of less than 2%. In this
study the analyte response is 10 times greater than the
noise response. For this study six replicates of the
analyte at lowest concentration in the calibration
range were measured and quantified.
Average Baseline Noise obtained from Blank =
98.1936 µV
Signal Obtained from LOD solution = 7985 µV
LOD = 3.3×σ/s
= 3.3×98.1936/7985
= 0.0405
LOQ = 10×σ/s
= 10×98.1936/7985
= 0.1229
System precision and System suitability
System precision and system suitability studies were
carried out by injecting six replicates of the working
standard solution. The % RSD for the peak areas
obtained was calculated. The data presented in Table
2.3.9 (% RSD<1) establishes reproducible
performance of the instrument. The system suitability
parameters are given in Table 2.3.10.
Assay calculation:
%Assay = × × × × ×
.
Where,
TA = peak area response due to Nelarabine from
sample
SA = peak area response due to Nelarabine from
standard
SW = Weight of Nelarabine working standard taken
in mg
P = purity of Nelarabine working standard taken
on as is basis
L.A = Labeled amount of Nelarabine in mg
%Assay =
862111/845634x31.25x2/25x200/2x99.2/100x100/5
= 100.192%
CONCLUSION
The present study was aimed at developing a
sensitive, precise and accurate HPLC method for the
analysis of NELARABINE in bulk drug and in
pharmaceutical dosage forms. using C18 column,
flow rate was 1.0ml/min, mobile Phase:
Trifluoroacetic acid buffer solution pH 3.6 ±0.05 and
solvent mixture (Acetonitrile) in (90:10 v/v).
Detection wave length was 248nm.The instrument
used was WATERS HPLC auto sampler. The
retention times were found to be 4.003 mins. The
analytical method was validated according to ICH
guidelines (ICH Q2b). The correlation coefficient (r2)
was found to be 0.998, % recovery was 101.76-
98.72% and %RSD for precision on replicate injection
was 0.43 and intermediate precision for intraday
precision at condition- I, II and III was 0.7, 0.2 and
0.3 interday precision at condition-I,II and III was
1.2,0.3 and 0.3 respectively. The precision study was
precise, robust, and repeatable. LOD value was
0.0405 and LOQ value was 0.1229.
The deliberate changes in the method have not much
affected the peak tailing, theoretical plates and the
percent assay. This indicates that the present method
is robust. The lowest values of LOD and LOQ as
obtained by the proposed method indicate the method
is sensitive. The standard solution of the drug was
stable up to 24 hours as the difference in percent assay
is within limit.
System suitability parameters were studied with six
replicates standard solution of the drug and the
calculated parameters are within the acceptance
criteria.
The tailing factor, the number theoretical plates and
HETP are in the acceptable limits. Hence the author
concludes that the proposed HPLC method is
sensitive and reproducible for the analysis of
NELARABINE in pharmaceutical dosage forms with
short analysis time.
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Figures:
Chemical Structure:
Fig.2 Linearity Plot for the proposed method
Table 1 Optimized Chromatographic conditions and system suitability parameters for proposed HPLC
Parameter Chromatographic conditions
S.No Parameter
1
Column
2
Mobile phase
3
Flow rate
4
Run time
5
Column temperature
0
500000
1000000
1500000
2000000
2500000
3000000
0
peakarea
International Journal of Trend in Scientific Research and Development, Volume 1(4), ISSN: 2456
Figure.1
Linearity Plot for the proposed method
Optimized Chromatographic conditions and system suitability parameters for proposed HPLC
method for Nelaribine
Parameter Chromatographic conditions
Parameter Value
Column
Cosmicsil Adza C-18
(150x4.6mm), 5µm
Mobile phase
Trifluoro acetic acid pH-3.6
buffer and Acetonitrile in the
ratio of 90:10 v/v
Flow rate 1mL/min
Run time 15.0 min
Column temperature 25±10
C
y = 16454x + 31764
R² = 0.997
20 40 60 80 100 120 140
concentration
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518
Optimized Chromatographic conditions and system suitability parameters for proposed HPLC
3.6
buffer and Acetonitrile in the
y = 16454x + 31764
R² = 0.997
160
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6
Volume of injection 10 µL
7
Detection wave length 248nm
8
Retention time of the drug 4.003 min
Table.2 Accuracy
S.NO
Conc. Of
Nelarabine in
ppm
Nelarabine
peakArea
1 25 442399
2 50 862111
3 75 130223
4 100 1630614
5 125 2045323
6 150 2512346
Table.3 Calibration of the proposed HPLC Method
Concentration of
NELARABINE (μg/mL)
Peak Area
25 442399
50 862111
75 1302223
100 1630614
125 2045323
150 2546233
Table.4 Regression characteristics of the linearity plot of NELARABINE
Parameter Value
Linearity Range (μg) 25-150
Slope (a) 16264
Intercept (b) 30585
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Correlation coefficient 0.998
Regression Equation Y = 16264X + 30585
Table.5. Precision of the proposed method
Concentration
of
NELARABINE
(µg/mL)
Intra-day Precision Inter-day Precision
Mean SD % RSD Mean
amount
found
(n=9)
SD % RSD
25 445202 3132.96 0.7% 448172 8624.2 1.2%
50 860569 1947.16 0.2% 858664 2784.8 0.3%
75 1356106 4428.01 0.3% 1304275 4832.2 0.3%
Table.6 Accuracy data (Triplicate values at different concentration levels)
Spike
Level
Conc µg/m Conc µg/ml Amount found %
Recovery
Mean %
Recovery
Amount added (pure) Amount added
(formulation)
80% 8 10 7.864 101.84
101.768 10 7.872 101.72
8 10 7.863 101.73
100% 10 10 10.022 99.64
99.3510 10 10.030 99.77
10 10 10.024 99.72
120% 12 10 12.156 98.65
98.7212 10 12.147 98.81
12 10 12.176 98.70
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Table.7
Variations in the
flow rate
Peak area Average % RSD
0.9ml/min
864511
866702 0.2%867732
867865
1.1ml/min
865567
867083 0.1%867783
867899
Table.8
Variations in the
PH
Peak area Average % RSD
3.4
865577
867451 0.1%867883
868894
3.8
866221
867297 0.1%867783
867889
Table.9
Variations in the
temperature
Peak area Average % RSD
280
c
588678
588780 0.018%588772
588892
310
c
867745
867509 0.07%866785
867998
Table.10 System precision
Injection No. Peak area
1 845634
2 857096
3 866190
4 853829
5 850789
6 859723
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Mean 855543
SD 7138.6
% RSD 0.8%
Table.11 System suitability parameters
Parameters Values
Theoretical plates (n) 4890
Plates per meter (N) 7509
Tailing factor (T) 1.08
LOD 0.0405
LOQ 0.1229