RP-HPLC stability indicating assay and simultaneous estimation method for the combination of Glecapravir and Pibrentasvir in tablet dosage form

Abstract

Glecaprevir & Pibrentasvir are directly acting antiviral agents and Hepatitis C virus (HCV) protease inhibitors which targets on viral RNA replication. The main objective of the present work is to determine a simple, precise, accurate RP-HPLC method. In RP-HPLC, the method was developed using Waters Alliance 2695 separation module with PDA detector, Altima 5μ C18 column 4.6×150mm & Empower Software. The mobile phase used was Methanol: TEA Buffer pH 4.5: Acetonitrile (50:35:15) at a flow rate of 1ml/min. The method was validated for System Suitability, Specificity, Linearity, Accuracy, Precision, Robustness & Forced Degradation Studies (Acidic, Basic, Oxidative). The %RSD was found to be <2.0% and all the other validation parameters were found to be within the limits. This method can be used for the routine determination of Glecaprevir and Pibrentasvir in bulk drug and in Pharmaceutical dosage forms.