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Development of Validated Stability Indicating RP-HPLC Method for the Estimation of Glecaprevir and Pibrentasvir in Bulk and Pharmaceutical Dosage Form

Sangameshwar B. Kanthale, Sanjay S. Thonte, Debarshi Kar Mahapatra.

Abstract
A novel, selective, precise, and sensitive stability indicating RP-HPLC method has been developed and validated for simultaneous estimation of Glecaprevir (GLE) and Pibrentasvir (PIB) for bulk and pharmaceutical dosage form. The chromatographic separation was accomplished on a Denali C18 column (150 mm 4.6 mm, 5μm) by using mobile phase buffer (pH 4.8) and acetonitrile in the ratio of 60:40 v/v. An injection volume of 10 μL was used via manual rheodyne and the solute was detected at a UV wavelength of 260 nm. The mobile phase was pumped at an ambient temperature of 30C with a flow rate of 1 ml/min. The retention time of GLE and PIB were found to be 2.13 min and 3.46 min, respectively. The Q2b validation of the proposed analytical method revealed several features; linear regression analysis data showed good linearity over the concentration range 25-150 μg/mL for GLE and 10-60 μg/mL for PIB with r2 of 0.999 in both the cases, the mean recovery of the were found to be 100.33% and 100.47%, respectively. The accuracy and precision aspects expressed < 2% RSD value along with adequate robustness. The acid, alkali, neutral, dry heat, UV, and photo-degradation studies demonstrated the formation of various degradation products. The proposed analytical method proved to be suitable for the routine simultaneous analysis of both the drug in bulk and tablet formulations.

Key words: Glecaprevir; Pibrentasvir; Simultaneous; Validation; Degradation; Stability studies






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The articles in Bibliomed are open access articles licensed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License (https://creativecommons.org/licenses/by-nc-sa/4.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.