Stability indicating RP-HPLC method for simultaneous estimation of emtricitabine, bictegravir and tenofovir alafenamide in bulk and formulation

Abstract

A simple, accurate, precise method was developed for the simultaneous estimation of the Emtricitabine, Bictegravir and Tenofovir Alafenamide by rp-hplc method in solid dosage form. Chromatogram was run through Zodiac C18 150x4.6mm, 5m. Mobile phase containing Buffer and Acetonitrie in the ratio of 55:45 v/v was pumped through column at a flow rate of 1ml/min. Buffer used in this method was 0.1%OPA. Temperature was maintained at 30°C. Optimized wavelength   for Emtricitabine,Bictegravir and Tenofovir Alafenamide was 272.0 nm. Retention time of Emtricitabine, Bictegravir and Tenofovir Alafenamide were found to be 2.276 min, 2.289 min and 3.574 min. %RSD of system precision for Emtricitabine, Bictegravir and Tenofovir Alafenamide were and found to be 0.5, 0.5 and 0.7 respectively. %RSD of method precision for Emtricitabine, Bictegravir and Tenofovir Alafenamide were and found to be 0.4, 0.5 and 0.8 respectively. % recovery was obtained as 100.02%, 99.99% and 99.99% for Emtricitabine, Bictegravir and Tenofovir Alafenamide respectively. LOD values are obtained from regression equations of Emtricitabine, Bictegravir and Tenofovir Alafenamide were 3.25ppm, 0.83ppm, 0.37ppm and LOQ values are obtained from regression equations of Emtricitabine, Bictegravir and Tenofovir Alafenamide were 9.86ppm, 2.53ppm, and 1.13 ppm respectively. Regression equation of Emtricitabine was y = 10176x + 39244. Bictegravire was y = 9175.x + 5995and of Tenofovir Alafenamide was y = 6993.x + 996.1.