Novel Method Development, Validation and Forced Degradation Studies for the Concurrent Determination of Lamivudine, Tenofovir Disoproxil Fumarate and Doravirine in Active Pharmaceutical Ingredient and Formulation using RP-UPLC

Abstract

The main objective of proposed method is to develop, validate & to perform the forced degradation studies for the simultaneous quantification of lamivudine, doravirine and tenofovir in active pharmaceutical ingredient (API) and formulation using reverse phase ultra-performance liquid chromatography (RP-UPLC). The estimation was performed using HSS C18 (100mm×2.1mm,1.8µ)column with acetonitrile and 0.1 % ortho phosphoric acid (OPA) (35:65) as mobile phase ran in isocratic mode at rate of flow 0.3ml/min. The column temperature maintained at 30°C and detection wavelength used was 260nm. The developed method validated as per ICH guidelines. Method obeyed Beer’s law in the range of concentration of 37.5µg/ml – 225µg/ml, 37.5µg/ml – 225µg/ml and 12.5µg/ml – 75µg/ml for lamivudine, tenofovir and doravirine respectively. The method is stable when exposed to different stressed conditions with less degradation. For regular analysis of estimate of lamivudine, tenofovir, and doravirine in tablet formulation, this UPLC method can be employed