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

Abstract

Development and validation of RP-HPLC method for the simultaneous determination of Glecaprevir & Pibrentasvir in pure form and their combined tablet dosage forms. The current separation was achieved on a Chromasil ODS Column (4.6 x 250mm, 5.0 μ) using the composition of the mobile phase of (0.1 M KH 2 PO 4 buffer: methanol) in the ratio of (60:40) at pH 4.5. The pump flow rate was adjusted after several one milliliter per minute and both the samples were separated at 230nm. The retention times are 1.7 min and 2.3 min, for Glecaprevir and Pibrentasvir 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, oxidation, photolysis of the RP-HPLC method. Both medications were tested under various stress forced conditions, including alkali, acid, oxidative, photodegradation, & hydrolysis degradation. The accuracy limit is the percentage recovery should be in the range of 98.0% - 101.0%. The total recovery was found to be 99.69% and 99.39% for Glecaprevir and Pibrentasvir. The validation of developed method shows that the accuracy is well within the limit, which shows that the method is capable of showing good accuracy and reproducibility. The robustness limit for mobile phase variation and flow rate variation are well within the limit, which shows that the method is having good system suitability and precision under given set of conditions.