Vol. 8, Issue 1 (2019)

Author(s):
J Saroja, PV Anantha Lakshmi, Y Rammohan and D Divya

Abstract:
A sensitive, selective, reproducible and accurate stability indicating RP-HPLC method was developed for the estimation of glecaprevir and pibrentasvir in the presence of their stress degradation products. Degradation studies of glecaprevir and pibrentasvir were carried out in acidic, alkaline, oxidative, thermal and photolytic stress conditions. Separation was performed on YMC C18 analytical column using 0.1M potassium dihydrogen phosphate: methanol: acetonitrile (40:35:25, v/v/v). Peaks at retention times 1.955 min and 3.189 min were recognized as glecaprevir and pibrentasvir, respectively, and were quantified by measurements at wavelength 228 nm using photodiode array detector. The suggested method showed a linear range of 25–200 µg/ml with LOD and LOQ of 0.950 and 3.167 ng/ml for glecaprevir, and 10-80 µg/ml with LOD and LOQ of 0.273 and 0.910 µg/ml for pibrentasvir. The proposed method was applied successfully to the quantification of glecaprevir and pibrentasvir in commercial tablet formulation. The proposed RP-HPLC method can be applied for routine analysis of glecaprevir and pibrentasvir in the presence of stress degradation products in the bulk as well as combined tablet formulation.