DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING UPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF OMBITASVIR, PARITAPREVIR AND RITONAVIR IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Abstract

A rapid, accurate, precise and stability-indicating UPLC method was developed and validated for the simultaneous estimation of Ombitasvir, Paritaprevir and Ritonavir in bulk drugs and pharmaceutical dosage forms. Chromatographic separation was achieved using a BEH C18 column with 0.01 N potassium dihydrogen phosphate buffer and acetonitrile (60:40, v/v). The method was validated according to ICH Q2(R2) guidelines and demonstrated excellent specificity, linearity, accuracy, precision, robustness and sensitivity. Forced degradation studies confirmed its stability-indicating capability. The developed method is suitable for routine quality control and stability testing of the combined pharmaceutical formulation.