Abstract

Objective: The objective of the present work is to develop a simple, efficient, and reproducible spectrophotometric method for the quantitative estimation of hepatitis-C drug - Daclatasvir in active pharmaceutical ingredient (API) form and in pharmaceutical dosage form Methods: The developed ultraviolet spectrophotometric method for the quantitative estimation of hepatitis-C drugs - Daclatasvir based on measurement of absorption at a wavelength maximum (λmax) of 317 nm using methanol as solvent. Results: The method was validated in terms of, precision, linearity, accuracy, and robustness, LOD, LOQ as per the ICH guidelines. The method was found to be linear in the range of 50-150% for Daclatasvir. The percentage recovery values were in the range of 99.9-100.9% for Daclatasvir at different concentration levels. Relative standard deviation for precision and intermediate precision results were found to be <2%. The correlation coefficient value observed for Daclatasvir drug substances was not <0.99, 0.99, respectively. Results obtained from the validation experiments prove that the developed method is quantified for the estimation of Daclatasvir drug substances. Conclusion: The developed method can be successfully applied for routine analysis, quality control analysis, and also suitable for stability analysis of Daclatasvir in API & its pharmaceutical dosage form as per the regulatory requirements. Keywords: Daclatasvir, Method development, Validation, Ultraviolet-visible spectrophotometry.

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