A novel UPLC method to estimate glecaprevir and pibrentasvir simultaneously in tablets

Abstract

An accurate, sensitive and precise UPLC method has been established for the simultaneous quantitative analysis of glecaprevir and pibrentasvir and validated as per ICH guidelines. The resolutionof both the drugs was accomplished utilizingAcquity UPLC CSH C18 column (100 x 2.1 mm; 1.7 mm)using a mobile phase mixture of 10 mM potassium dihydrogen phosphate buffer (pH 3.5) and acetonitrile with the composition of 70:30v/v.The mobile phase was pumped at a flow rate of0.3 mL/min. The column temperature was maintained at 30°C. The analytes were detected at 260 nm. The retention times found for glecaprevir and pibrentasvir were 0.9 and 1.4 min respectively. The developed UPLC method was validated for parameters like specificity, linearity, accuracy, precision and robustness. The specificity of the method was demonstrated by thelack of interference from its placebo and by stress degradation studiesonthe respective drug molecules. The assay was linear in the concentration ranges of 5–30µg/mLfor glecaprevir and 2-12 µg/mL for pibrentasvir. The accuracy of the method was between 98–102%. The method was found  to  be sensitive, robust  and  fairly suitable for the  simultaneous quantitation of glecaprevir and  pibrentasvir in tablet formulations. Forced degradation studies were performed on the drugs and the resulting degradation products did not interfere with the estimation of glecaprevir and pibrentasvir, demonstrating that the proposed method is specific for theirestimation