Bio-Analytical Method Development and Validation for Simultaneous Quantification of Glecaprevir and Pibrentasvir in Rat Plasma by Using RP-HPLC
Author(s): Prasanthi T* and Gowri Shankar D
Abstract
A novel bio-anlytical method was developed for the simultaneous determination of Glecaprevir and Pibrentasvir in rat plasma by using RP-HPLC method. The chromatographic separation was performed on Xterra RP18,(150 mm × 4.6 mm and 3.5 μm) column using the mobile phase ACN: 0.1% formic acid (50:50 v/v). The internal standard used was Voxilapre vir. Glecaprevir, Pibrentasvir and Voxilaprevir peaks were detected at 2.5min, 5.2 min and 6.3 min respectively. Linear response was obtained in the range of 0.15 μg/mL-2.25 μg/mL for Glecaprevir and 0.06 μg/mL-0.9μg/mL for Pibrentasvir. All of the parameters must be validated like selectivity, accuracy, precision, linearity, lower limit of quantification, matrix effect, and recovery reached the acceptance criteria under the following of US FDA guidelines