Development of validated stability indicating RP-HPLC method for the estimation of glecaprevir and pibrentasvir in bulk and pharmaceutical dosage form

Abstract

A novel, selective, precise, and sensitive stability indicating Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method has been developed and validated for simultaneous estimation of Glecaprevir (GLE) and Pibrentasvir (PIB) for bulk and pharmaceutical dosage form. The chromatographic separation was accomplished on a Denali C 18 column (150 mm 4.6 mm, 5 m) by using mobile phase buffer (pH 4.8) and acetonitrile in the ratio of 60:40 v/v. An injection volume of 10 l was used via manual rheodyne and the solute was detected at a UV wavelength of 260 nm. The mobile phase was pumped at an ambient temperature of 30C with a flow rate of 1 ml/minute. The retention time of GLE and PIB were found to be 2.13 and 3.46 minutes, respectively. The Q2b validation of the proposed analytical method revealed several features; linear regression analysis data showed good linearity over the concentration range 25-150 g/ml for GLE and 10-60 g/ml for PIB with r 2 of 0.999 in both the cases and the mean recovery of them were found to be 100.33% and 100.47%, respectively. The accuracy and precision aspects expressed <2% relative standard deviation value along with adequate robustness. The acid, alkali, neutral, dry heat, UV, and photo-degradation studies demonstrated the formation of various degradation products. The proposed analytical method proved to be suitable for the routine simultaneous analysis of both the drugs in bulk and tablet formulations. potential, morphology, encapsulation efficiency, and stability of microcapsules. The characterization results from each formulation reported that the ratio of mangosteen peel extract and maltodextrin at level 50%:50% (MP3) produced more proportional characteristics than other treatments. The formulation of mangosteen peel extract with maltodextrin at a balanced ratio could be used as an alternative supply and processing of functional food.