Abstract

DEVELOPMENT AND VALIDATION OF NEW RP-HPLC METHOD FOR THE DETERMINATION OF SOFOSBUVIR IN PURE FORM

P. Mohan Vikas*, Dr. T. Satyanarayana, D. Vinod Kumar, E. Mounika, M. Sri Latha, R. Anusha and Y. Sathish

ABSTRACT

The present work is concerned with application of simple, precise, accurate, reproducible and specific RP-HPLC method for estimation of Sofosbuvir in bulk. Separation of SFS was successfully achieved on a Hisil C18 (4.6 x 250mm, 5 μm) Waters or equivalent in an isocratic mode utilizing Phosphate Buffer (4.0 pH): Methanol (50:50%v/v) at a flow rate of 0.8 mL /min and eluate was monitored at 262 nm, with a retention time of 1.01 minutes. The method was validated and the response was found to be linear in the drug concentration range of 5 μg/mL to 30μg/mL. The values of the slope, intercept and the correlation coefficient were found to be 0.07, -0.4 and 1.000 respectively. The RSD values for system precision and method precision were found to be 0.19% (Intra-day), 0.21% (Inter-day) and 0.20% (Intra-day), 0.23% (Inter-day) respectively.

Keywords: Sofosbuvir (SFS), RP-HPLC, Phosphate Buffer (4.0 pH), Methanol.