Analytical Method Development and Validation of Stability Indicating RP-HPLC Method for The Simultaneous Estimation of Dolutegravir, Emtricitabine and Tenofovir Disproxil Fumarate

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Dolutegravir (DUA), Emtricitabine(ECB) and Tenofovir Disoproxil fumarate (TDF) tablet dosage form. Chromatogram was run through Std Kinetex Biphenyl, 250 x 4.6 mm, 5µm. Mobile phase-A containing pH-3.0 Ammonium acetate Buffer & Mobile phase -B containing Degassed mixture of Acetonitrile & Methanol taken in the ratio of 50:50 was pumped through column at a flow rate of 1 mL/min. Diluent used in this method was 0.1% Orthophosphoric acid buffer & Methanol in the ratio of 50:50%v/v. Temperature was maintained at 40°C. Optimized wavelength selected was 260 nm. Retention time of DUA, ECB and TDF were found to be 14.6min, 3.98min and 12.60min. %RSD of the DUA, ECB and TDF were found to be 0.35, 0.47 & 0.40 respectively. %Recovery was obtained as 98.9%, 99.6% and 99.3% for DUA, ECB and TDF respectively. Both the runtime and retention times were decreased, so this method developed was simple and economical this can be adopted in regular quality control in pharma industries.