METHOD DEVELOPMENT AND VALIDATION OF ULTRAVIOLET-VISIBLE SPECTROSCOPIC METHOD FOR THE ESTIMATION OF HEPATITIS-C DRUGS - DACLATASVIR AND SOFOSBUVIR IN ACTIVE PHARMACEUTICAL INGREDIENT FORM

Abstract

ABSTRACTObjective: The objective of the present work is to develop a simple, efficient, and reproducible spectrophotometric method for the quantitativeestimation of hepatitis-C drugs - Daclatasvir and Sofosbuvir in its active pharmaceutical ingredient (API) form.Methods: The developed ultraviolet spectrophotometric method for the quantitative estimation of hepatitis-C drugs - Daclatasvir and Sofosbuvir isbased on measurement of absorption at a wavelength maximum (λmax) of 317 and 261 nm using methanol as solvent.Results: The method was validated in terms of specificity, precision, linearity, accuracy, and robustness as per the ICH guidelines. The method wasfound to be linear in the range of 50-150% for Daclatasvir and in the range of 43-143% for Sofosbuvir. The percentage recovery values were in therange of 99.4-100.6% for Daclatasvir and in the range of 99.7-100.6% for Sofosbuvir at different concentration levels. Relative standard deviation forprecision and intermediate precision results were found to be <2%. The correlation coefficient value observed for Daclatasvir and Sofosbuvir drugsubstances was not <0.99, 0.99, respectively. Results obtained from the validation experiments prove that the developed method is quantified for theestimation of Daclatasvir and Sofosbuvir drug substances.Conclusion: The developed method can be successfully applied for routine analysis, quality control analysis, and also suitable for stability analysis ofDaclatasvir and Sofosbuvir in API form as per the regulatory requirements.Keywords: Daclatasvir, Sofosbuvir, Method development, Validation, Ultraviolet-visible spectrophotometry.