Development and validation of a stability indicating RP-HPLC method for estimation of daclatasvir in pharmaceutical dosage form

Abstract

Introduction: The aim of the present investigation is to develop and validate a novel, accurate, precise, and sensitive and stability indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantitative determination of daclatasvir in pure and pharmaceutical formulation. Materials and Methods: The method development was found to be having suitable applications for routine quality control analysis. Pharmaceutical analysis plays a key role in the Quality Assurance and Quality Control of bulk drugs. Analytical chemistry involves separating, identifying, and determining the relative amounts of components in a sample matrix. Pharmaceutical analysis is a specialized branch of analytical chemistry. Pharmaceutical analysis derives its principles from various branches of sciences such as physics, microbiology, nuclear science, and electronics. Qualitative analysis reveals the chemical identity of the sample. Results: To establish an optimized method, two trails were conducted with different compositions. Finally, the mobile phase selected for the analysis was composed of acetonitrile and 0.1% formic acid buffer adjusted to pH 4.5 in the ratio of 40: 60 v/v at flow rate of 1 mL/min. The maximum response was observed at 305 nm and was optimized for measuring the absorbance. The sharp peak of daclatasvir was retained at 4.34 min. Conclusion: By the obtained results and reports, the developed RP-HPLC method for the estimation of daclatasvir was found to be more efficient and accurate.