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) andPibrentasvir (PIB) for bulk and pharmaceutical dosage form. The chromatographic separation was accomplished ona Denali C18 column (150 mm × 4.6 mm, 5 µm) by using mobile phase buffer (pH 4.8) and acetonitrile in the ratio of60:40 v/v. An injection volume of 10 µl was used via manual rheodyne and the solute was detected at a UV wavelengthof 260 nm. The mobile phase was pumped at an ambient temperature of 30°C with a flow rate of 1 ml/minute. Theretention time of GLE and PIB were found to be 2.13 and 3.46 minutes, respectively. The Q2b validation of theproposed analytical method revealed several features; linear regression analysis data showed good linearity over theconcentration range 25–150 µg/ml for GLE and 10–60 µg/ml for PIB with r2 of 0.999 in both the cases and the meanrecovery 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, andphoto-degradation studies demonstrated the formation of various degradation products. The proposed analyticalmethod 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 eachformulation reported that the ratio of mangosteen peel extract and maltodextrin at level 50%:50% (MP3) producedmore proportional characteristics than other treatments. The formulation of mangosteen peel extract with maltodextrinat a balanced ratio could be used as an alternative supply and processing of functional food.