STABILITY-INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF SELECTED DRUGS IN BULK AND FORMULATIONS WITH GREENNESS ASSESSMENT USING GAPI

Abstract

Objective: A comprehensive, verified, and dependable RP-HPLC method was created to assess Velpatasvir and Sofosbuvir in bulk and fixed-dose combo tablets.

Methods: The chromatographic separation was conducted on a BDS C8 column with dimensions of 4.6 × 50 mm and a particle size of 5 µm. The mobile phase was a 50:50 v/v mixture of potassium dihydrogen phosphate buffer and HPLC-grade acetonitrile, which was pH-adjusted to 3.5 with 0.1% orthophosphoric acid. The detection wavelength was 288 nm, and the flow rate was 1.0 mL/min.

Results: In the concentration range of 2.5-15 µg/mL for Velpatasvir and 20-120 µg/mL for Sofosbuvir, the methodology consistently exhibits high correlation coefficients (R²) of 0.999, indicating exceptional linearity. Sofosbuvir exhibited a higher degree of precision than Velpatasvir, with a recovery rate of 100.11% in contrast to 99.31%. In order to verify the precision and robustness (with a %RSD of less than 2%), the ICH Q2(R1) principles were applied. Velpatasvir's LOD/LOQ values were 0.01/0.04 µg/mL, while Sofosbuvir's were 0.13/0.40 µg/mL.

Conclusion: The observed degradation levels state the method's specificity and applicability for quality control and stability testing, as they are within acceptable limits. The Green Analytical Procedure Index (GAPI) was employed to assess the method's environmental impact. Applicability for quality control and stability testing was also assessed. The method's environmental impact was evaluated using the Green Analytical Procedure Index (GAPI).