Abstract

STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF GLECAPREVIR AND PIBRENTASVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM

Kappera Srilatha*, Bakshi Anjali, Bhutada Shweta and Dr. M. Bhagvan Raju

Abstract

A simple, rapid, accurate and precise RP-HPLC method is developed for the determination of Glecaprevir and Pibrentasvir in bulk and dosage forms. Separation of the Glecaprevir and Pibrentasvir was achieved on a Cosmicsil C18 Column (250 mm x 4.6 mm, 5μm) using the mobile phase of (0.1M Phosphate buffer :Methanol) in the ratio of (65:35) at pH 4.5. The flow rate was 1.0ml/min using PDA detector at 225nm. The retention times are 1.663 min and 2.249 min, for Pibrentasvir and Glecaprevir respectively with linear ranges 20 μg/ml- 60 μg/ml and 50 μg/ml-150 μg/ml, The method was statistically validated for linearity, accuracy, precision and selectivity as per ICH guidelines. The drugs were subjected to stress conditions of hydrolysis (acid and base), oxidation, photolysis and thermal degradation to show the stability-indicating power of the developed RP-HPLC method. The present method can be successfully used for routine analysis of Glecaprevir and Pibrentasvir and stability studies.

Keywords: Glecaprevir, Pibrentasvir, RP-HPLC, Mavyret, validation.