UPLC STABILITY INDICATING METHOD FOR SIMULTANEOUS ESTIMATION OF GLECAPREVIR AND PIBRENTASVIRAbstract
A forced stability-indicating method for simultaneous estimation of glecaprevir and pibrentasvir by Ultra Performance Liquid Chromatography (UPLC) was developed and validated. The separation was done on column BEH C18 50 × 2.1mm 1.7m which was maintained at 30 °C, eluted with isocratic mobile phase and eluents were detected at 260nm. Mobile phase containing Buffer 0.01NKH2PO4: Acetonitrile taken in the ratio 50:50 was pumped through column at a flow rate of 0.3 ml/min. The retention time of glecaprevir and pibrentasvir was found to be 0.392 min and 0.607 min respectively. Validation with respect to specificity, system suitability, precision, accuracy, linearity, and robustness was performed as per ICH guidelines. % RSD of the glecaprevir and pibrentasvir were and found to be 0.5 and 0.7 respectively. % Recovery was obtained as 100.40 and 99.90% for glecaprevir and pibrentasvir respectively. LOD, LOQ values obtained from regression equations of glecaprevir and pibrentasvir were 0.79, 2.38 and 0.51, 1.55 respectively. Regression equation of glecaprevir is y = 2140x + 994.9 and of pibrentasvir was y = 2138.x + 314.3. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular quality control tests in Industries.
K. P. Kumari * and D. G. Sankar
Department of Pharmaceutical Analysis, Andhra University, Visakhapatnam, Andhra Pradesh, India.
29 May 2019
26 August 2019
30 November 2019
01 April 2020