Stability Indicating Method for Glecaprevir and Pibrentasvir Estimation in API and Tablets by Using Ultra-Performance Liquid Chromatography

The current study employed UPLC to assess Glecaprevir and Pibrentasvir in both API and tablets with degradation study and was validated using ICH Q2 recommendations. The isocratic mobile phase used was 0.01 M Ammonium Acetate and Acetonitrile in 30:70% v/v with 0.3 mL/min flow rate on ACQUITY CHS C 18 100x2.1mm, 1.7µm column, with temperature of the column at 30°C and wavelength of 248 nm. The sample was injected with an injection volume of 1.0 µl. The run time was set to 3 minutes. Results: Glecaprevir had a retention time of 1.116 minutes and Pibrentasvir of 1.502 minutes. The % RSD in the precision study for six preparations of Glecaprevir and Pibrentasvir was 0.5% and 1.0%. respectively. The calibration curves for Glecaprevir were linear from 12.5 to 75 µg/mL and 5 to 30 µg/mL for Pibrentasvir having a Correlation coefficient value of 0.9998 in the linearity analysis. The average % recovery was found to be between 99.6% for both drugs. Based on the Forced degradation results obtained, it was found that the drug was more degraded in acidic conditions. Conclusion: With respect to sensitivity, precision, accuracy, and cost-effectiveness, the newly created methodology outperformed the previously documented methods. So, it is suitable for regular analysis in quality control departments as it consumes less solvent, and performs faster analysis while maintaining sensitive detection limits.