Development and Validation of UV Spectrophotometric Method for the Estimation of Some Hepatitis-C Drugs in Bulk and in Formulations

The present work is to develop a simple, efficient, and reproducible UV spectrophotometeric method for the estimation of some hepatitis-C drugs Boceprevir and Simeprevir in bulk and in tablet dosage form. The developed method is based on measurement of absorption at a wavelength maximum (λmax) of 235 nm for Boceprevir and 225 nm for Simeprevir using methanol as solvent. Linearity was observed in the concentration range 2-12 μg/ml for both the drugs. The results of analysis have been validated statistically for linearity, precision, accuracy, LOD and LOQ as per ICH guidelines. The % assay for the pure sample was found to be 100.33% for Boceprevir and 100.50% for Simeprevir. Recovery studies for the method was found to be 101.02%, 101.35% and 100.18% for Boceprevir and 102.03%, 101.45% and 101.18% for Simeprevir. The developed method was found to be accurate, precise, selective and rapid for spectrophotometeric analysis of Boceprevir and Simeprevir in bulk and in dosage forms.