Monday , 20 May 2024

Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Determination of Glecaprevir and Pibrentasvir in Its Bulk and Their Pharmaceutical Dosage Forms

MD. Abdul Sattar1*, A. Suneetha2
1University College of Pharmaceutical Sciences, Acharya Nagarjuna University, Nagarjuna Nagar, 522510,Guntur(Dist), Andhra Pradesh, India

2Depatment  of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi Road, Guntur- 522002, Andhra Pradesh, India

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 pH 4.5 and the mobile phase was optimized with consists of Methanol: Phosphate buffer mixed in the ratio of PH 4.5(20:80 v/v). Kromosil C18 Column (250mm x 4.6mm) 5µg 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 mg/ml of Glecaprevir and 1-5mg/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 LOD and LOQ were found to be within limit. The results obtained on the validation parameters met ICH and USP requirements.
Keywords: Kromosil C18, Glecaprevir and Pibrentasvir, RP-HPLC

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