Stability-indicating HPLC method for simultaneous estimation of Glecaprevir and Pibrentasvir, application to in-vitro dissolution studies

Abstract

New HPLC method have been developed for simultaneous analysis of Glecaprevir/Pibrentasvir in pharmaceutical dosage form and applied to portray the in-vitro dissolution profiles of drug product. The title analytes were eluted rapidly with 2.5% sodium taurocholate in phosphate buffer, pH 4.5 and methanol (80: 20 v/v) on Kromosil C18 Column (250 x 4.6 mm, 5μ). The detection was carried out using PDA detector at 254 nm. The solutions were chromatographed at a constant flow rate of 1 ml/min. Method was validated as ICH guidelines. The linearity range of Glecaprevir and Pibrentasvir were found to be 10–300 μg/ml and 4–120 μg/ml, respectively. Low % RSD values in precision studies indicates the reproducibility of method. The percentage recovery varies 98–102%, found to be within the limits. The proposed validated method was fruitfully applied for the assay, stability and in-vitro dissolution studies of marketed dosage forms containing Glecaprevir and Pibrentasvir.