A New RP-hplc method for Simultaneous Estimation of Glecaprevir and Pibrentasvir in Its Pure and Pharmaceutical Dosage Form

Abstract

An efficient and simple HPLC method has been developed and validated for the simultaneous determination of glecaprevir and pibrentasvir in bulk and was applied on marketed glecaprevir and pibrentasvir products. The mobile phase used for the chromatographic runs consisted of phosphate buffer (pH 3.0) and acetonitrile (80:20, v/v) The separation was achieved on an Inertsil ODS (4.6 x 250mm, 5µ) column using isocratic mode. Drug peaks were well separated and were detected by a UV detector at 230 nm. The method was linear at the concentration range 50–125 µg/ml for glecaprevir and 10–50 µg/ml for pibrentasvir  respectively.  The  method  has  been  validated  according  to  ICH  guidelines  with  respect  to  system  suitability, specificity, precision, accuracy and robustness.