Stability Indicating HPLC Method for the Simultaneous Determination of Sofosbuvir and Velpatasvir

Abstract

Aim: Effective pharmaceutical techniques are necessary to guarantee the quality, safety, and effectiveness of antiviral medication combinations employed for managing Hepatitis C, a dangerous viral disease that affects millions of people worldwide. This work's objective was to develop and validate a straightforward quick accurate these stability-indicating reverse phase high-performance liquid chromatographic technique for the combined measurement by the drug velpatasvir with sofosbuvir. Materials and Methods: Luna phenyl hexyl column 150×46 mm 35 mm and an isocratic solvent system made up of acetonitrile and 01 trifluoroacetic acid in a 30:70 v/v ratio chromatographic separation was accomplished the flow rate was kept constant at 10 mL/min using monitoring using a 10 µg/mL injection volume also detection of wavelength of 261 nm ICH recommendations for system compatibility linearity, consistency, correctness, specificity robustness detection limit LOD and quantification of limit LOD were followed in the validation of developed method forced degradation experiments in acidic alkaline oxidation-induced, heat-induced light-induced and neutral conditions also used to assess stability-indicating capabilities with Results and Conclusion: Retention time roughly 277 min sofosbuvir and 512 min for velpatasvir the data showed satisfactory chromatographic separation within the concentration intervals of 1060 µg/mL for sofosbuvir and 530 µg/mL for velpatasvir the technique exhibited excellent linearity with correlation coefficients near unity accuracy studies produced percentage recovery whereas precision studies revealed RSD values below 2 values ranging from 99 to 101 for routine quality evaluation of sofosbuvir and velpatasvir over bulk substance forms the established RP-HPLC technology is hence dependable stability-assessing and suitable