Stability-indicating HPLC method for simultaneous estimation of Glecaprevir and Pibrentasvir, application to in-vitro dissolution studies Mamata Dhanavath1*, Sapavatu Srinu Naik2, Patnaik KSK Rao2 1Department of Pharmacy, University College of Technology, Osmania University, Hyderabad, Telangana, India, 500007 2Department of Chemical Engineering, University College of Technology, Osmania University, Hyderabad, Telangana, India, 500007 *Corresponding Author E-mail: mamatadhanavath@gmail.com
Online published on 30 April, 2021. 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. Top Keywords Glecaprevir, Pibrentasvir, RP-HPLC, Dissolution, Degradation. Top |