RP- HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF GLECAPREVIRAND PIBRENTASVIR IN PHARMACEUTICAL DOSAGE FORM

High performance liquid chromatography is at present one of the most sophisticated tool of the analysis. The estimation of Glecaprevir and Pibrentasvir was done by RP-HPLC. The Phosphate buffer was p(H)4.5 and the mobile phase was optimized with consists of Methanol: Phosphate buffer mixed in the ratio of P-H 4.5(20: 80 v/v). kromosil C-18 Column (250mm x 4.6mm) 5 mu g or equivalent chemically bonded to porous silica particles was used as stationary phase. The detection was carried out using UV detector at 254 nm. The solutions were chromatographed at a constant flow rate of 1 ml min(-1). the linearity range of Glecaprevir and Pibrentasvir were found to be from 100-500 mu g/ml of Glecaprevir and 1-5 mu g/ml of Pibrentasvir. Linear regression coefficient was not more than 0.999. The values of % RSD are less than 2% indicating accuracy and precision of the method. Glecaprevir % RSD 0.2 and Pibrentasvir % RSD 0.6. Intermediate precision for Glecaprevir % RSD 0.2 and Pibrentasvir % RSD 0.1 The percentage recovery varies from 98-102% of Glecaprevir and Pibrentasvir. LOD and LOQ were found to be within limit. The results obtained on the validation parameters met ICH and USP requirements. it inferred the method found to be simple, accurate, precise and linear. The method was found to be having suitable application in routine laboratory analysis with high degree of accuracy and precision.