Development and validation of stability indicating RP-HPLC method for the estimation of Elbasvir and Grazoprevir in bulk and pharmaceutical dosage form

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Elbasvir and Grazoprevir in tablet dosage form. Chromatogram was run through Denali C18 150 x 4.6 mm, 5m. Mobile phase containing Buffer 0.1% OPA (2.8ph): Acetonitrile taken in the ratio 600:30 was pumped through column at a flow rate of 0.8 ml/min. Buffer used in this method was 0.1% OPA. Temperature was maintained at 30°C. Optimized wavelength selected was 260 nm. Retention time of Elbasvir and Grazoprevir were found to be 2.143 min and 2.694 min respectively. The drug was stressed under alkaline, oxidative, thermal, photolytic degradation were analysed. The developed method was validated as per ICH guidelines The Accuracy, Linearity, Precision, and Robustness were within the acceptance limits .Hence this HPLC method was a stability indicating method can be used for routine stability analysis of the Elbasvir and Grazoprevir in Pharmaceutical dosage forms.