Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Glecapravir and Pibrentasvir in API and Marketed Formulation

Y. Suresh*¹, Sanjay Kumar Jain^2
1Safa College of Pharmacy, Kurnool, Andhra Pradesh, India
²Department of Pharmaceutical Analysis, Bundelkhand University, Jhansi, U.P, India

A B S T R A C T
The present attempt was made to development of validated RP-HPLC method for the simultaneous estimation Glecapravir and Pibrentasvir in bulk and pharmaceutical dosage form. The chromatographic separation was carried on Xterra C18 column (4.6 x 150mm, 5mm)column and maintained flow rate was 1.0 ml/min. Detection of absorption maxima was monitored at 251 nm. The optimized mobile phase was consisting of 0.1%  OPA buffer and  Methanol in the ratio of 30:70 %v/v. The retention time Glecapravir was 2.205 min and Pibrentasvir was 4.996 min. The linearity was made to the 100-500 ppm for Glecapravir and 40-200 ppm for Pibrentasvir with correlation coefficient was found to be not more than 0.999 for both drugs. In precision studies % RSD was found to be less than 2%. The mean percentage recovery was found to be  within the limit. All the validation parameters are statically validated with ICH guidelines. So the developed method can be applied for that routine quality control analysis of Glecapravir and Pibrentasvir in analytical laboratories.
Keywords: Glecapravir, Pibrentasvir, RP-HPLC, Retention time, Mobile phase, Validation