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Abstract

New RP-HPLC method have been developed for simultaneous analysis of simeprevir and sofosbuvir in pharmaceutical formulation and applied to stability studies of drugs. The analytes were quickly eluted using a phosphate buffer at pH 3.50 and acetonitrile in a 25:75 %v/v ratio on a Hypersil BDS C18 column measuring 150 x 4.6 mm with a particle size of 5 µm. The detection was facilitated using a PDA detector at a wavelength of 253 nm. The analytes went through chromatography at a steady flow rate of 1 mL/min. Simeprevir and sofosbuvir were eluted at 2.1 min. and 5.3 min., respectively, demonstrating good resolution. The method was validated in accordance with ICH guidelines. The linearity range of simeprevir was determined to be 25 - 75 µg/mL, while for sofosbuvir, it was found to be 10 - 30 µg/mL.  The % RSD values (< 2) in precision studies indicate the method's reproducibility. The percentage recoveries were 100.1% for simeprevir and 99.36% for sofosbuvir, both of which were found to be within the acceptable limits. The validated method was effectively utilized for the assay of formulation and stability studies of drugs under various stress conditions..