Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry

Abstract

UPLC Method for the Quantification of Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Disoproxil Fumarate in Tablets Using OGD Reference Dissolution Medium

Author(s): Vittal SP, Rao SM and Ramakrishna K*

The current paper discuss about strategic development and validation activity performed for quantification of Elvitegravir (EL), Cobicistat (CO), Emtricitabine (EM) and Tenofovir Disoproxil fumarate (TDF) in a combination drug product using Office of Generic drugs (OGD) recommended Dissolution medium. Ultra Performance Liquid Chromatographic (UPLC) technique method was chosen and developed a method with a run time of four minutes. Mobile phase A consists of 0.1% perchloric acid and Mobile phase B consists of Acetonitrile. Gradient elution technique was opted with an optimized flow rate of 0.3 ml per minutes. Acquity UPLC BEHC18 (100 mm × 2.1 mm ID), 1.7 particle size column is finalized for testing purpose with a detection wavelength of 260 nm. Typical retention times observed for EM, TDF, CO and EL are 0.89, 1.42, 2.01 and 2.77 min respectively. Method is found to be linear over the specified concentration of 3.71- 44.56 μg/ml of EL, 1.77-21.23 μg/ml for CO, 4.90-58.74 μg/ml for EM and 7.37-88.40 μg/ml for TDF with correlation coefficient more than 0.99. Accuracy of the drugs is found to be more than 90% in proposed OGD medium. Developed method could be useful to quantify the drugs in pharmaceutical quality control and contract research laboratories for dissolution profiles at very fast rate.


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