Abstract
Analytical Method Development and Validation for Estimation of Emtricitabine in Tablet Dosage Form by Reverse Phase High Performance Liquid Chromatography
Department of Pharmaceutical Chemistry, Dr. D. Y. Patil College of Pharmacy, Pune Maharashtra 411035, India
Correspondence Address:
Shital Rathod, Department of Pharmaceutical Chemistry, Dr. D. Y. Patil College of Pharmacy, Pune Maharashtra 411035, India, E-mail: shitalrathod541@gmail.com
The aims of research is to develop and validates appropriate ultraviolet spectroscopy and reverse phase high performance liquid chromatography method for analyzing Emtricitabine in a dosage form which are accurate, sensitive and reproducible methods. For the ultraviolet spectroscopy we use wavelength of 280 nm using methanol as solvent and we also validate parameters such as linearity, accuracy, limit of detection, limit of quantification were studied, similarly for reverse phase high performance liquid chromatography method we using methanol (high performance liquid chromatography grade):water (high performance liquid chromatography grade) in the ratio of (60:40) and various validation parameters are evaluated for Emtricitabine by reverse phase high performance liquid chromatography which are determined according to International Council for Harmonization Q2B guidelines. Both the regression coefficient (r2 ) was found to be 0.99 and 0.99 for ultraviolet and reverse phase high performance liquid chromatography respectively. The proposed method are effective, highly sensitive, precise and accurate and hence used for determination of Emtricitabine.
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