STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND LEDIPASVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM

Pathipati Himabindu*, Pavan Kumar V., Dasu Phaneendra Kumar, Gobala Krishnan P. and Munisekhar V.

ABSTRACT

A new simple, accurate, rapid and precise method was developed and validated for the simultaneous estimation of Sofosbuvir and Ledipasvir in pharmaceutical dosage form. Chromatogram was run through Standard discovery C18 (250 x 4.6 mm, 5μ) Column. Mobile phase contains Potassium Dihydrogen Phosphate Buffer: Acetonitrile taken in the ratio 45:55 was pumped through column at a flow rate of 1 ml/min. The pH was adjusted to 3.2 with Orthophosphoric acid. Temperature was maintained at 25°C. Optimized wavelength selected was 243 nm. The retention times were found to be 2.836 and 3.678 minutes for Sofosbuvir and Ledipasvir. % RSD of the Sofosbuvir and Ledipasvir were found to be 0.5 and 0.3 respectively. % Recovery was obtained as 99.12% and 100.12% for Sofosbuvir and Ledipasvir respectively. LOD, LOQ values obtained from regression equations of Sofosbuvir and Ledipasvir were found to be 0.11, 0.33 and 0.17, 0.48 respectively. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

Keywords: Sofosbuvir, Ledipasvir, RP-HPLC, Stability, Validation.