ULTRA PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF GLECAPREVIR IN PHARMACEUTICAL DOSAGE FORMS

Abstract

Glecaprevir is an antiviral drug used in combination with other drugs includes sofosbuvir, ribavirin, and interferon, depending on the virus type to treat cirrhosis caused by hepatitis C (HCV). Several methods have been found for quantification, but those are not cost-effective, and they are time-consuming. The present study developed a simple, precise, accurate and cost-effective UPLC method to determine Glecaprevir quantity in tablet dosage forms. A simple and selective UPLC method is described for the determination of Glecaprevir Chromatographic separation was achieved on a Acquity BEH C18 (50 × 3.0mm. 1.7 µm) using a mobile phase consisting 0.1% of Orthophosphoric acid: Acetonitrile in a ratio of 60:40 v/v with detection of 248 nm. Linearity was observed in the range 50-150 µg/ml for Glecaprevir (r² = 1.000). The amount of drugs estimated by the proposed method was in good agreement with the label claim. The proposed method was validated as per ICH guidelines and applied for the determination of the cited drug in the dosage form.