DEVELOPMENT AND VALIDATION OF LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS DETERMINATION OF SOFOSBUVIR, VELPATASVIR AND VOXILAPREVIR IN FIXED TABLET DOSAGE FORM
Marakada Sridevi, Dr. T. Siva Rao* and Challa Gangu Naidu
ABSTRACT
Developing a single analytical method for the estimation of individual drugs is very challenging due to the formation of drug-drug and drug-excipient interactions. The present study demonstrates the applicability of the chromatographic method to develop a new, sensitive, single HPLC method for the simultaneous quantitative determination of three antiviral agents in the fixed pharmaceutical dosage form. Chromatographic separation of the three antiviral drugs was achieved by using a isocratic elution at a flow rate of 1.0 mL/min on Spursil ODS C18 column (150m×4.6mm, 5μm particle size) at ambient temperature. Potassium dihydrogen orthophosphate KH2PO4 (0.03M) in 1000 ml of water and by adjusting the pH to 3.0 with diluted sodium hydroxide. Mobile phase composition is 85% of buffer and 15% of Acetonitrile and UV detection at 245 nm was employed to monitor the analytes. A linear response was observed for Sofosbuvir over the concentration range 100-600 μg/ mL, 25-150 μg/ mL of Velpatasvir and 25-150μg/ mL of Voxilaprevir.
Keywords: Sofosbuvir, Velpatasvir and Voxilaprevir, Isocratic -HPLC, Vosevi, Method Development, and validation.
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