Stability indicating high performance liquid chromatography method development and validation for simultaneous estimation of Glecaprevir and Pibrentasvir in bulk and pharmaceutical dosage form

A simple, accurate and precise method was developed for the simultaneous estimation of the Glecaprevir [GPV] and Pibrentasvir [PNV] in Tablet dosage form by using HPLC. The chromatogram was run through Std. Zodiac column (150 × 4.6 mm, 5μ) by using the mobile phase containing Buffer 0.1% OPA: Acetonitrile taken in the ratio 55:45. The flow rate maintained at 1 ml/min. and temperature set to 30°C. Optimized wavelength selected was 260 nm. The retention time of GPV and PNV were found to be 2.207 min and 3.263 min. %RSD of the GPV and PNV were and found to be 0.2 and 0.1 respectively. Average % Assay of marketed formulation of Glecaprevir and Pibrentasvir obtained was 99.56 and 99.25% respectively. LOD, LOQ values obtained from regression equations of GPV and PNV were 0.32, 0.97 and 0.04, 0.11 respectively. Regression equation of GPV was y = 23779x + 9673 and of PNV was y = 13508x + 2326. From the experimental results, the retention times were decreased and run time was decreased, so that the method developed was simple and economical that can be adopted in regular Quality control test in Industries.