Formulation of sustained release dosage form of simvastatin and ezetimibe and analytical development by reversed phase high performance liquid chromatography (RP-HPLC)
Formulation of sustained release dosage form of simvastatin and ezetimibe and analytical development by reversed phase high performance liquid chromatography (RP-HPLC)
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.
Development and validation of HPLC method for the estimation of Escitalopram ...SriramNagarajan15
A simple, specific, robust, accurate and precise isocratic HPLC method has been developed and subsequently validated for simultaneous determination of escitalopram (ESP) in pharmaceutical dosage forms. Kromosil (250x4.6)mm 5µ with flow rate of 1ml/ min by using JASCO PU-1580 and UV/VIS JASCO UV-1570 at 238 nm. The separation was carried out using a mobile phase consisting of acetonitrile, methanol and 5mM ammonium acetate buffer (pH 3.0) in the ratio 30:20:50 respectively. The retention time for escitaloparm was found to be 5.36 minutes respectively. The correlation coefficient was found to be 0.9997 (ESP). The mean percentage recovery was found to be 101.86 respectively. The % estimation of the drugs was found near to 100 % representing the accuracy in the method. The proposed method was also validated and applied for the analysis of drugs in tablet formulation.
There is high demand for oxysterol quantitation due to their correlation with neurodegenerative diseases. The ratios of various oxysterols in biological fluids are used by researchers to study disease states. This application presents a fast, sensitive LC-MS/MS method using the LCMS-8060, with detection quantitation limits determined using multiple reaction monitoring mode for each analyte.
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.
Development and validation of HPLC method for the estimation of Escitalopram ...SriramNagarajan15
A simple, specific, robust, accurate and precise isocratic HPLC method has been developed and subsequently validated for simultaneous determination of escitalopram (ESP) in pharmaceutical dosage forms. Kromosil (250x4.6)mm 5µ with flow rate of 1ml/ min by using JASCO PU-1580 and UV/VIS JASCO UV-1570 at 238 nm. The separation was carried out using a mobile phase consisting of acetonitrile, methanol and 5mM ammonium acetate buffer (pH 3.0) in the ratio 30:20:50 respectively. The retention time for escitaloparm was found to be 5.36 minutes respectively. The correlation coefficient was found to be 0.9997 (ESP). The mean percentage recovery was found to be 101.86 respectively. The % estimation of the drugs was found near to 100 % representing the accuracy in the method. The proposed method was also validated and applied for the analysis of drugs in tablet formulation.
There is high demand for oxysterol quantitation due to their correlation with neurodegenerative diseases. The ratios of various oxysterols in biological fluids are used by researchers to study disease states. This application presents a fast, sensitive LC-MS/MS method using the LCMS-8060, with detection quantitation limits determined using multiple reaction monitoring mode for each analyte.
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.
In this study, a new Shimadzu electrolytic suppressor was used as part of a Shimadzu modular IC system to determine inorganic anions according to methods EPA 300.
IOSR Journal of Pharmacy (IOSRPHR), www.iosrphr.org, call for paper, research...iosrphr_editor
IOSR Journal of Pharmacy (IOSRPHR), www.iosrphr.org, call for paper, research paper publishing, where to publish research paper, journal publishing, how to publish research paper, Call for research paper, international journal, publishing a paper, call for paper 2012, journal of pharmacy, how to get a research paper published, publishing a paper, publishing of journal, research and review articles, Pharmacy journal, International Journal of Pharmacy, hard copy of journal, hard copy of certificates, online Submission, where to publish research paper, journal publishing, international journal, publishing a paper
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.
VALIDATED LIQUID CHROMATOGRAPHY/TANDEM MASS SPECTROMETRY METHOD FOR DETERMINA...Manik Ghosh
A simple, highly sensitive and rapid LC-MS/MS method has been developed and validated for the quantification of metolazone in rat plasma using irbesartan as internal standard (IS). After simple protein precipitation extraction by acetonitrile, the analyte and IS were extracted from 50 μL plasma sample on an Agilent Poroshell 120, EC- C18 (50 mm × 4.6 mm, i.d., 2.7 μm) column using 5μL injection volume with a total run time of 2 min. Acidified methanol/water mixture was used as a mobile phase. The parent/product ion transitions for metolazone (m/z 366.1/258.9) and IS (m/z 429.2/207.0) were monitored on a triple quadrupole mass spectrometer, operating in the multiple reaction monitoring and positive ion mode. The method was found to be linear in the range of 0.05 – 200 metolazone. The method was validated with respect to selectivity, linearity, accuracy, precision, recovery and stability according to accepted regulatory guidelines. The described method was successfully applied to preclinical pharmacokinetic studies of analytes after an oral administration of metolazone (1 mg/kg) in rats.
Method development and validation of escitalopram and estizolam in tablet dos...SriramNagarajan19
A simple and selective LC method is described for the determination of Escitalopram oxalate and Etizolam 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 238 nm. Linearity was observed in the range 60-140 µg/ml for Escitalopram oxalate (r2 =0.999) and 6-14 µg /ml for Etizolam (r2 =0.996) 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.
This presentation showcases two UHPLC-PDA methods to separate three isomers of tocopherol (vitamin E). The quick 5-minute method will allow for vitamin E identification and quantitation, while the 10-minute method will also allow for determination between nicotine or cannabinoid-based products.
Combination drugs containing Paracetamol and Aspirin, displayed in Figure 1, are widely used analgesics with anti-inflammatory properties for treatment of migraines. Both active ingredients have a similar mode of action, whereby they inhibit the cyclooxygenase (COX) enzyme, by preventing the production of prostaglandins which cause pain, inflammation, and fever. UV/Vis spectrometry is a fast and commonly used technique in quality control laboratories for routine analysis of purity and quantity of components within various stages of a product’s manufacture in many industries.
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
New RP HPLC method for the estimation of imatinib in pharmaceutical dosage formSriramNagarajan19
A simple and selective LC method is described for the determination of Imatinib dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a mixture of Water: Acetonitrile (30:70 v/v), with detection of 272nm. Linearity was observed in the range 50-150 µg /ml for Imatinib (r2 =0.9976) 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 for the estimation of Atorvastatin, Ezitimi...SriramNagarajan18
Method development and validation for the estimation of Atorvastatin, Ezitimibe and Fenofibrate in bulk and pharmaceutical dosage forms by RP-HPLC method
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.
In this study, a new Shimadzu electrolytic suppressor was used as part of a Shimadzu modular IC system to determine inorganic anions according to methods EPA 300.
IOSR Journal of Pharmacy (IOSRPHR), www.iosrphr.org, call for paper, research...iosrphr_editor
IOSR Journal of Pharmacy (IOSRPHR), www.iosrphr.org, call for paper, research paper publishing, where to publish research paper, journal publishing, how to publish research paper, Call for research paper, international journal, publishing a paper, call for paper 2012, journal of pharmacy, how to get a research paper published, publishing a paper, publishing of journal, research and review articles, Pharmacy journal, International Journal of Pharmacy, hard copy of journal, hard copy of certificates, online Submission, where to publish research paper, journal publishing, international journal, publishing a paper
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.
VALIDATED LIQUID CHROMATOGRAPHY/TANDEM MASS SPECTROMETRY METHOD FOR DETERMINA...Manik Ghosh
A simple, highly sensitive and rapid LC-MS/MS method has been developed and validated for the quantification of metolazone in rat plasma using irbesartan as internal standard (IS). After simple protein precipitation extraction by acetonitrile, the analyte and IS were extracted from 50 μL plasma sample on an Agilent Poroshell 120, EC- C18 (50 mm × 4.6 mm, i.d., 2.7 μm) column using 5μL injection volume with a total run time of 2 min. Acidified methanol/water mixture was used as a mobile phase. The parent/product ion transitions for metolazone (m/z 366.1/258.9) and IS (m/z 429.2/207.0) were monitored on a triple quadrupole mass spectrometer, operating in the multiple reaction monitoring and positive ion mode. The method was found to be linear in the range of 0.05 – 200 metolazone. The method was validated with respect to selectivity, linearity, accuracy, precision, recovery and stability according to accepted regulatory guidelines. The described method was successfully applied to preclinical pharmacokinetic studies of analytes after an oral administration of metolazone (1 mg/kg) in rats.
Method development and validation of escitalopram and estizolam in tablet dos...SriramNagarajan19
A simple and selective LC method is described for the determination of Escitalopram oxalate and Etizolam 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 238 nm. Linearity was observed in the range 60-140 µg/ml for Escitalopram oxalate (r2 =0.999) and 6-14 µg /ml for Etizolam (r2 =0.996) 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.
This presentation showcases two UHPLC-PDA methods to separate three isomers of tocopherol (vitamin E). The quick 5-minute method will allow for vitamin E identification and quantitation, while the 10-minute method will also allow for determination between nicotine or cannabinoid-based products.
Combination drugs containing Paracetamol and Aspirin, displayed in Figure 1, are widely used analgesics with anti-inflammatory properties for treatment of migraines. Both active ingredients have a similar mode of action, whereby they inhibit the cyclooxygenase (COX) enzyme, by preventing the production of prostaglandins which cause pain, inflammation, and fever. UV/Vis spectrometry is a fast and commonly used technique in quality control laboratories for routine analysis of purity and quantity of components within various stages of a product’s manufacture in many industries.
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
Stability indicating method development and validation for the estimation of ...
Similar to Formulation of sustained release dosage form of simvastatin and ezetimibe and analytical development by reversed phase high performance liquid chromatography (RP-HPLC)
New RP HPLC method for the estimation of imatinib in pharmaceutical dosage formSriramNagarajan19
A simple and selective LC method is described for the determination of Imatinib dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a mixture of Water: Acetonitrile (30:70 v/v), with detection of 272nm. Linearity was observed in the range 50-150 µg /ml for Imatinib (r2 =0.9976) 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 for the estimation of Atorvastatin, Ezitimi...SriramNagarajan18
Method development and validation for the estimation of Atorvastatin, Ezitimibe and Fenofibrate in bulk and pharmaceutical dosage forms by RP-HPLC method
Haemolysis effect of Mefenamic Acid 250 mg Capsule in Bio analysis by liquid ...IOSR Journals
A rapid, simple and specific method for estimation of Mefenamic acid in human plasma was validated using Indomethacin as internal standard. The analyte and internal standard were extracted from plasma using simple solid phase extraction. The compound were separated on a reverse-phase column with an isocratic mobile phase consisting of 2 mM Ammonium Acetate in Water and acetonitrile (20:80, v/v) and detected by tandem mass spectrometry in negative ion mode. The ion transition recorded in multiple reaction monitoring mode were m/z 240.1 196.0 for Mefenamic acid and m/z 356.1312.0 for internal standard. Linearity in plasma was observed over the concentration range 35.000 – 7000.000 ng/mL for Mefenamic acid. The cv of the assay was 4.89 % to 5.98 % and accuracy was 99.36 to 102.20 % Intra and Interday respectively at LLOQ level. The validated method was applied to bioequivalence study of 250 mg Mefenamic acid in 28 healthy human volunteers. Total 50 samples from individual volunteers identified as Haemolyzed which were analyze initial and repeat again to cross check the method reproducibity for Haeamolysis effect and compared which found acceptable range
Development and Validation of Stability Indicating Method for Simultaneous Es...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 sulbactum and ceftriaxo...SriramNagarajan19
A simple and selective LC method is described for the determination of Sulbactum and Ceftriaxone tablet dosage forms. Chromatographic separation was achieved on a C18 column using mobile phase consisting of a mixture of mixture of 60 volumes of 20mM Phosphate buffer pH 3.5: 40 volumes of Acetonitrile (60:40 v/v) with detection of 210 nm. Linearity was observed in the range 30-70 µg /ml for Sulbactum (r2 =0.9998) and 60-140µg /ml for Ceftriaxone (r2 =0.9983) 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.
Novel RP-HPLC Method for Simultanious Determination of Sitagliptin and Simvas...iosrphr_editor
A simple, rapid, accurate, precise and novel high-performance liquid chromatographic method for simultaneous analysis of Sitagliptin and SIMV in pharmaceutical dosage form has been developed and validated. The chromatographic separation was accomplished on Welchrom RP-C18 Column (250 mm X 4.6 mm; 5μm), Shimadzu LC-20AT Prominence Liquid Chromatograph and with a mixture of 10 mM Phosphate buffer: acetonitrile and methanol in the range of (45:35:20 v/v/v). The flow rate was fixed at 1mL/minute and the analysis was performed using Shimadzu SPD-20A Prominence UV-detection was performed at 255 nm. The Sitagliptin and Simvastatin were separated within seven minutes. The retention time for SITA and SIMV was found to be 3.352 minutes and 5.402 minutes respectively. The calibration plots were linear over the concentration range of 10-50 μg/mL for SITA (r2 = 0.9998) and 4-20 μg/mL for SIMV (r2 = 0.9999). There was no interference due to commonly used excipients. The relative standard deviation for inter-day precision was lower than 2.0 % which obviously indicates that the present method was said to be highly precise. Regarding accuracy of the developed method the % RSD were also found less than 2 % which shows the method is completely accurate. The method was very sensitive with regard to LOD 0.681 μg/mL, 0.116 μg/mL and LOQ 2.250 μg/mL, 0.384 μg/mL respectively. The mean assay values for SITA and SIMV were determined in tablet dosage form were found to be within limits. The developed RP HPLC method was found to be simple, rapid, sensitive, highly precise and accurate highly suitable for routine analysis of drug samples containing Sitagliptin and Simvastatin.
Quantification of a Novel Peptide, CPT31 in Rat and Monkey Plasma by LC-MSCovance
ASMS 2019 -- CPT31, a novel D-peptide, is being investigated in the treatment and prevention of HIV by inhibiting the viral entry of HIV. To evaluate the properties of CPT31, an accurate highly reproducible method to quantitate CPT31 in plasma was required. To this end, a robust LC-MS assay for the quantification of CPT31 in rat and monkey plasma samples is reported here. The method follows extraction and clean-up of two plasma matrices, encompasses a range of 90.0 to 45,000 ng/mL, and completes LC-MS analysis in 7.50 minutes.
COMPARATIVE INVESTIGATION OF FOOD SUPPLEMENTS
CONTAINING ASCORBIC ACID
Danka Obreshkova and Boyka Tsvetkova
Medical University – Sofia, Faculty of Pharmacy, Dept. of Pharmaceutical chemistry
Abstract. A simple, specific, precise and accurate reversed phase liquid chromatographic (RP-LC) method
has been developed for the determination of ascorbic acid in different food additives. The chromatographic
separation was achieved on a LiChrosorb C18, 250 mm x 4.6 mm, 5 μm column at a detector wavelength
of 230 nm and a flow rate of 1.5 ml/min. The mobile phase was composed of acetonitrile and water (60:40
v/v). The retention time of analyte was 3.49 min. The method was validated for the parameters like specificity,
linearity, precision, accuracy, limit of quantitation and limit of detection. The method was found to be
specific as no other peaks of impurities and excipients were observed. The square of correlation coefficient
(R2) was 0.9997 while relative standard deviations were found to be <2.0%. The proposed RP-LC method
can be applied for the routine analysis of commercially available food additives of ascorbic acid.
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
Similar to Formulation of sustained release dosage form of simvastatin and ezetimibe and analytical development by reversed phase high performance liquid chromatography (RP-HPLC) (20)
Stability indicating method and validation for the simultaneous estimation of...SriramNagarajan18
Stability indicating method and validation for the simultaneous estimation of metformin and empagliflozin by using RP-HPLC in a bulk and pharmaceutical dosage forms
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New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Best Ayurvedic medicine for Gas and IndigestionSwastikAyurveda
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Pharma Pcd Franchise in Jharkhand - Yodley Lifesciences
Formulation of sustained release dosage form of simvastatin and ezetimibe and analytical development by reversed phase high performance liquid chromatography (RP-HPLC)
1. Ayesha B et al / Int. J. of Farmacia, Vol-1, Issue 1, July- Sep. 2015, Pg. 30-36
30
International Journal of Farmacia
Journal Home page: www.ijfjournal.com
Formulation of sustained release dosage form of simvastatin and ezetimibe
and analytical development by reversed phase high performance liquid
chromatography (RP-HPLC)
Ayesha Begum K*, Pavani Kasu, Sunitha M
Bharat Institutute of Engineering and Technology, Mangalpally, Ibrahimpatanam, Hyderabad,
Telangana 501510
*Email: Ayesha_Begum@gmail.com
Abstract
The present investigation relates to a process of preparing sustained release dosage forms containing simvastatin and
ezetimibe in combination and assay by RP-HPLC method development and validation. Chromatographic separation
was achieved on a Water’s Xterra column (250 x 4.6, 5 microns) using a mobile phase consisting of Potassium di
hydrogen phosphate and methanol in the ratio of 70:30 at a flow rate of 0.8 ml per minute. The detection was made
at 236 nm. The retention time of ezetimibe and simvastatin were 2.6 and 3.4 minutes respectively. The proposed
method was validated for Accuracy, Specificity, Precision, linearity, Robustness, Limit of Detection (LOD) and
Limit of Quantitation (LOQ) were studied as per the ICH guidelines.
Key words:Ezetimibe, Simvastatin, Sustained release dosage forms, Reversed phase high performance liquid
chromatography, Limit of detection and limit of quantitation.
INTRODUCTION
Simvastatin is chemically (1S,3R,7S,8S,8aR)-8-{2-
[(2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-
yl]ethyl}-3,7-dimethyl-1,2,3,7,8,8a-
hexahydronaphthalen-1-yl 2,2-dimethylbutanoate.
Simvastatin is in a group of drugs called HMG CoA
reductase inhibitors, or "statins." It reduces levels of
"bad" cholesterol (low-density lipoprotein, or LDL)
and triglycerides in the blood, while increasing levels
of "good" cholesterol (high-density lipoprotein, or
HDL). Ezetimibeis chemically (3R,4S)-1-(4-
fluorophenyl)-3-(4- fluorophenyl)-3- hydroxypropyl]-
4-(4-hydroxyphenyl)azetidin-2-one. Ezetimibe is a
drug that lowers plasma cholesterol levels. It acts by
decreasing cholesterol absorption in the small
intestine. It may be used alone when other cholesterol-
lowering medications are not tolerated, or together
with statins (e.g., ezetimibe/simvastatin,) when statins
alone do not control cholesterol. Ezetimibe reduces the
amount of cholesterol absorbed by the body.The
present investigation describes a process of preparing
sustained release dosage form containing simvastatin
and ezetimibe in combination and assay by RP-HPLC
method and its validation.
MATERIALS AND METHODOLOGY
Simvastatin, Ezetimibe, hydrochloric acid, Potassium
di hydrogen phosphate, Methanol, Acetonitrile, HPLC
grade water, Citric acid, Croscarmellose
Sodium(CCS), Hydroxy Propyl Cellulose (HPC),
Lactose, Magnesium stearate micro crystalline
cellulose (MCC).
Construction of calibration curve of ezetimibe and
simvastatin
A calibration curve was plotted over a concentration
range of 3-18 µg/mL Simvastatin, 5-30 µg/mL
Ezetimibe. The absorbance of each solution was
measured at the wavelengths 238.2nm, 243.3nm and
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31
247.6.nm.Calibration curves were constructed for
Simvastatin and Ezetimibe by plotting absorbance
versus concentrations at both wavelengths.
Validation of assay method
specificity
Specificity is the ability to assess unequivocally the
analyze in the presence of components which may be
expected to be present. Specificity will be performed
to ensure that no co-elution of process impurities and
its degradation product exists. Specificity will be
demonstrated by injecting the standard solution as per
described procedure.
Precision
To experiment the repeatability of standard solution
obtained by this method. The precision shall be
demonstrated by preparing six standard solutions as
per the test method. The precision of method will be
evaluated by computing the %RSD of the Area count.
Linearity
Demonstrate the linearity of analyte over the range of
50% to 150% of standard concentration.
Acceptance criteria The correlation coefficient is
NLT 0.99.
Accuracy
Accuracy of the test method shall be demonstrated by
preparing accuracy samples in 50 mL volumetric flask
at the level of 50%, 100%, and 150% of samples
concentration. The accuracy samples will be prepared
in triplicate in each level.
Acceptance criteria
The Recovery for all levels should be between 98%-
102%.
Limit of detection (LOD)
Limit of Detection (LOD) of Ezetimibe and
Simvastatin by the proposed methods were determined
using calibration standards. LOD were calculated as
3.3 s/S where S is the slope of the calibration curve
and s is the standard deviation of y-intercept of
regression equation. The low values indicated the good
sensitivity of the method proposed.
Limit of quantitation (LOQ)
Limit of Quantitation (LOQ) of Ezetimibe and
Simvastatin by the proposed methods were determined
using calibration standards.LOQ were calculated as 10
s/S where S is the slope of the calibration curve and s
is the standard deviation of y-intercept of regression
equation. The low values indicated the good
sensitivity of the method proposed.
Robustness
To establish the robustness of test method and to
demonstrate its reliability for minor changes in
chromatographic conditions Robustness of test method
will be demonstrated by carrying out systemsuitability
under normal condition and each of the altered
conditions.
Acceptance criteria
Following system suitability parameters to be
evaluated should comply with all altered conditions.
Table 1: System suitability parameters for all altered conditions (Robustness)
S. No Test Specifications
1. Tailing of Ezetimibe and Simvastatin in SST solution NMT 2
2. Resolution of Ezetimibe and Simvastatin in SST solution NLT 2
3. Number of theoretical plates for
Ezetimibe and Simvastatin peak in SST solution
NLT 2500
RESULTS AND DISCUSSION
Assay of ezetimibe and simvastatin tablet dosage form
Table 2: System suitability Parameters
Test Specifications
Resolution R between Ezetimibe and Simvastatin peak NLT 2
%RSD for area response ofEzetimibe and Simvastatin peak obtained with the
six replicate measurement of standard solution
NMT 2.0%
No. of theoretical plates for Ezetimibe and Simvastatin peak in SST NLT 2500
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Similarity factor of Ezetimibe and Simvastatin in SST 0.98-1.02
Percentage recovery
Table 3: Percentage recovery of Ezetimibe in tablet dosage form
Formulation Label claim
(mg/tablet)
10 tablets
average weight
Amount obtained by
proposed method
Percentage
recovery
Ezetimibe 10 mg 1668.86 mg 39.57 µg/ml 99.1%
Table 4: Percentage recovery of Simvastatin in tablet dosage form
Formulation Label claim
(mg/tablet)
10 tablets
average weight
Amount obtained by
proposed method
Percentage
recovery
Simvastatin 10 mg 1668.86 mg 39.83 µg/ml 99.7%
Fig.1: Overlay Spectrum ofSimvastatin andEzetimibe
Standard calibration curve of ezetimibe
It was found that the estimation of Ezetimibe by UV
spectrometric method at λ max 247.6 nm in Methanol
and Water in the proportion of 40:60.
Standard calibration curve of simvastatin
It was found that the estimation of Ezetimibe by UV
spectrometric method at λ max 238.2 nm in Methanol
and Water in the proportion of 40:60.
Optimized method
EZETIMIBE-2.595
SIMVASTATIN-3.427
AU
0.00
0.10
0.20
0.30
0.40
0.50
0.60
0.70
0.80
0.90
1.00
Minutes
0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00
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100% 500.66 8652379 79.760 79.76 100
100% 500.66 8642852 79.760 79.67 100 100
100% 500.66 8651434 79.760 79.75 100
150% 750.99 12976891 119.640 119.62 100
150% 750.99 12911408 119.640 119.02 99
150% 750.99 12910234 119.640 119.01 99 100
150% 750.99 12987883 119.640 119.72 100
150% 750.99 12906798 119.640 118.98 99
150% 750.99 12991328 119.640 119.76 100
Acceptance criteria
The Recovery for all levels of accuracy
should be between 97%- 103%.
The recovery results indicating that the
method has an acceptable level of accuracy
for the assay of Ezetimibe and Simvastatin
from 50% to 150% of test concentration (Fig:
8.35-8.49 & Table: 8.18-8.25).
LOD and LOQ
Fig. 2: Typical Chromatogram of Fig. 3: Typical Chromatogram of
LOD LOQ
Table 9: Summary Table of LOD and LOQ - Ezetimibe
Table 10: Table for LOD and LOQ - Simvastatin
Analyte LOD LOD LOQ LOQ
Concentration (µg/ml) S/N ratio Concentration (µg/ml) S/N ratio
Simvastatin 40 2.1317 40 7.1058
The low values indicated the good sensitivity of the method proposed
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Table 11: Table of Robustness
S.No Altered Conditions RT- Ezetimibe RT - Simvastatin Area- Ezetimibe Area - Simvastatin
1 TEMP1 2.595 3.434 7203005 8428624
2 TEMP2 2.585 3.391 7158913 8351520
3 FLOW1 3.231 4.275 9076098 10584420
4 FLOW2 2.165 2.859 5880030 6860347
MEAN 7329511.5 8556227.75
STD 1316139.4 1532727.725
% RSD 0.03% 0.03%
The experiment proves the reliability of the test method for minor changes in the chromatographic conditions.
CONCLUSION
In the present study, a new RP-HPLC method is
developed for the estimation of Simvastatin and
Ezetimibe which is simple, less time consuming using
an economical column. The analysis is resolved by
using Potassium di hydrogen phosphate: Methanol
(70:30) as mobile phase at a flow rate of 0.8 ml/min
using Water’s Xterra column (250 x 4.6; 5µ) on an
isocratic HPLC system. There was no interference
observed from other impurities and Simvastatin and
Ezetimibe has been eluted with good peak shape,
response within 6 min. The assay of the sample has
been carried out using this new method and it was
found to be 99.1% and 99.7% respectively. The
developed method has been validated for different
parameters like Specificity, Precision, Linearity,
Accuracy, Robustness, LOD and LOQ. It was
concluded that the order of extending the release of the
drug increase with the increase in the coating
concentration of the polymer. All the results obtained
were within the acceptance limits indicating that the
developed method is simple, specific accurate and
economical.
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