scholarly journals Development and validation of a stability indicating high-performance liquid chromatography (HPLC) method for the estimation of isoniazid and its related substances in fixed dose combination of isoniazid and ethambutol hydrochloride tablets

2011 ◽  
Vol 5 (12) ◽  
pp. 1513-1521 ◽  
Author(s):  
J. Ayyappan
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Hplc Method ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Stability Indicating ◽  
Related Substances ◽  
Dose Combination ◽  
Development And Validation

scholarly journals STABILITY-INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ROSUVASTATIN CALCIUM AND CLOPIDOGREL BISULFATE IN PHARMACEUTICAL DOSAGE FORM BY REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

2020 ◽  
pp. 84-90
Author(s):  
AWDHUT PIMPALE ◽  
RAJENDRA KAKDE
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Hplc Method ◽  
Tablet Formulation ◽  
Simultaneous Estimation ◽  
Stability Indicating ◽  
Clopidogrel Bisulfate ◽  
Rp Hplc ◽  
Development And Validation

Objective: The present work was focused on the development and validation of reversed-phase high-performance liquid chromatography (RP-HPLC) method which is simple, rapid, precise, accurate, sensitive, economical, and stability-indicating for the quantification of rosuvastatin (RSV) calcium and clopidogrel bisulfate (CLO) in bulk and tablet formulation. Methods: The separation was attained on RP Princeton (C18) column with dimensions (250 mm × 4.6 mm, 5 μ) employing buffer which is a mixture of water (pH 3.0, adjusted with orthophosphoric acid), and methanol in the ratio (20:80) v/v as mobile phase, at flow rate 1.0 ml/min and detection was carried out at wavelength 240 nm. The retention time under the optimized condition of RSV calcium and CLO was found to be 2.844 min and 4.388 min, respectively. Results: The linearity of the method was demonstrated in the concentration range of 6–16 µg/ml and 45–120 µg/ml for RSV calcium and CLO with a correlation coefficient (r2) of 0.9999 and 0.9996, respectively. The percentage relative standard deviation was ˂2% and percentage recovery was found to be 100.12–101.37% and 99.72–101.09% for RSV calcium and CLO, respectively. Assay of marketed tablet formulation was found to be 98.99% and 99.92%, respectively. Conclusion: The developed RP-HPLC method was found to be simple, specific, sensitive, rapid, linear, accurate, precise, and economical and could be used for regular quality control of RSV calcium and CLO in bulk and tablet formulations.

scholarly journals STABILITY-INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ROSUVASTATIN CALCIUM IN BULK AND TABLET FORMULATION BY REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

2019 ◽  
pp. 251-256
Author(s):  
SAILAJA B ◽  
SRAVANA KUMARI K
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Hplc Method ◽  
Tablet Formulation ◽  
Reverse Phase ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Development And Validation ◽  
Rosuvastatin Calcium

Objective: The present work was focused on the development and validation of reverse-phase high-performance liquid chromatography (RP-HPLC) method which is simple, rapid, precise, accurate, sensitive, economical, and stability indicating for the quantitation of rosuvastatin calcium in bulk and tablet formulation. Methods: The separation was attained on Waters Symmetry C18 column with dimensions 150×4.6 mm, 5 mm particle size employing 0.1% orthophosphoric acid buffer:acetonitrile in the ratio of 55:45% v/v as mobile phase, which was pumped at a rate of 1.0 ml/min and detected at a wavelength of 241 nm. Results: The linearity of the method was demonstrated in the concentration range of 2–12 μg/ml for rosuvastatin calcium with a correlation coefficient (r2) of 0.999, percentage drug recovery was found to be 100.22–101.16%, and percentage relative standard deviation <2. Limit of detection and limit of quantitation values were found to be 0.013 μg/ml and 0.042 μg/ml, respectively, and assay of marketed tablet formulation was found to be 99.76%. Conclusion: The developed RP-HPLC method was found to be simple, specific, sensitive, rapid, linear, accurate, precise, and economical and could be used for regular quality control of rosuvastatin calcium in bulk and tablet formulation.

scholarly journals A REVIEW ON DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHODS FOR ANALYSIS OF ACIDIC DRUGS

2019 ◽  
pp. 22-33
Author(s):  
DEVYANI M. RODE ◽  
NUTAN N. RAO
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Biological Samples ◽  
High Performance ◽  
Hplc Method ◽  
Pharmaceutical Drugs ◽  
Stability Indicating ◽  
Acidic Drugs ◽  
Degradation Studies ◽  
Development And Validation

High-performance liquid chromatography is one of the fastest, safest and precise technology used for determination and separation of pharmaceutical drugs, impurities and biological samples. High-performance liquid chromatography is versatile and it takes less time for quantification of drugs as compared to old liquid chromatography techniques. This article reviews stability indicating HPLC method developed and validated for acidic drugs and their degradation studies.

High performance liquid chromatography (HPLC) method development and validation for the determination of flunixin: Animal plasma based study

2021 ◽  
pp. 1-11
Author(s):  
Sultan M. Alshahrani ◽  
John Mark Christensen
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Method Development ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Limit Of Quantification ◽  
Mobile Phases ◽  
Hplc Method Development ◽  
Development And Validation

This study was designed to develop and validate a simple and efficient high performance liquid chromatography (HPLC) method to determine flunixin concentrations in Asian elephant’s (Elephas maximus) plasma. Flunixin was administered orally at a dose of 0.8 mg/kg, and blood samples were collected. Flunixin extraction was performed by adding an equal amount of acetonitrile to plasma and centrifuging at 4500 rpm for 25 minutes. The supernatant was removed, and flunixin was analyzed using HPLC-UV detection. Two methods were developed and tested utilizing two different mobile phases either with or without adding methanol (ACN: H2O vs. ACN: H2O: MeOH). Both methods showed excellent linearity and reproducibility. The limit of detection was 0.05 ug/ml and limit of quantification was 0.1 ug/ml. the efficiency of flunixin recovery was maximized by the addition of methanol to mobile phase (ACN: H2O: MeOH as 50:30:20) at 95% in comparison to 23% without methanol. In conclusion, adding methanol to HPLC methods for extraction of flunixin from elephants’ plasma yielded higher recovery rate than without methanol.

DEVELOPMENT AND VALIDATION OF HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULPHATE IN PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (01) ◽  
pp. 35-40
Author(s):  
A. S. Bagde ◽  
V. V. Khanvilkar ◽  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Liquid Chromatography Method ◽  
Development And Validation ◽  
Dextromethorphan Hydrobromide

The present work describes a validated reverse phase high performance liquid chromatography (RPHPLC) method for simultaneous estimation of dextromethorphan hydrobromide and quinidine sulphate in pharmaceutical dosage from. The drugs were resolved using Hemochrom Intsil C18-5U column (250×4.6) mm in isocratic mode with mobile phase methanol: water (0.08% diethylamine, 0.02% of glacial acetic acid and pH 4.4 adjusted with orthophosphoric acid) in the ratio of 70:30 V/V at a flow rate of 1.0 mL/min. Retention time of dextromethorphan hydrobromide and quinidine sulphate were 4.9±0.2 and 3.6±0.2, respectively, at 292nm. The above mentioned method was validated as per International Conference on Harmonization (ICH) guidelines. Linear responses were obtained in concentration ranges of 5-35 μg/mL for dextromethorphan hydrobromide and 4-16 μg/mL for quinidine sulphate, with correlation coefficient (r2) of 0.999 for both the drugs. A simple, selective, accurate, precise, robust and reliable RP-HPLC method thus developed and validated for simultaneous estimation of dextromethorphan hydrobromide and quinidine sulphate.

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