Analytical method development and validation of emtricitabine, bictegravir, tenofovir alafenamide by RP-HPLC

Abstract

A simple and precise method was developed for estimating Emtricitabine, Bictegravir and Tenofovir Alafenamide. The method

was found to be specific and precise. The separation was attained on Symmetry C18 (150 × 4.5mm, 5µm)column with Water :

Acetonitrile : Methanol (15:35:50) % v/v as mobile phase at a flow rate of 1.0 ml/min and linearity was achieved in the

concentration range of 50% to 150% of standard concentration with correlation coefficient 0.99. The percent recovery from the

assay was found to be 100.80%for Emtricitabine, 100.34% for Bictegravirand 100.64% for Tenofovir Alafenamide. Specificity

and precision studies for Emtricitabine, Bictegravir and Tenofovir Alafenamide were within the acceptable range. From the

stability studies, the percentage variation was less than 10.0% which is the desired criteria. Therefore, this method can be

adopted to estimate Emtricitabine, Bictegravir and Tenofovir Alafenamidein other pharmaceutical formulations.