Validation of a Cost-Effective RP-HPLC Method for Quantitative Investigation of Daclatasvir Dihydrochloride in Pharmaceutical Formulations

Abstract

A well-known direct-acting antiviral (DAA) drug called daclatasvir may be used to treat chronic hepatitis C virus (HCV) infection. Herein, we reported a selective, precise, and a cost-effective analytical method for the measurement of an active pharmaceutical ingredient (API) of daclatasvir dihydrochloride in drug substances as well as drug products via the reversed-phase RP-HPLC technique. To obtain greater separation, the majority of the chromatographic conditions were improved. Best separation findings were achieved under chromatographic conditions with an HPLC column of USP L1 (150 × 4.6 mm, 5 μm) by utilizing a combination of acetonitrile and buffer solution of KH2PO4 (30 : 70, v/v) as a mobile phase at a stream rate of 1 mL.min−1 with a finding at 300 nm and a column temperature of 40°C. Linearity was examined in the range of 90–210 ppm (R2 = 0.999) for daclatasvir dihydrochloride. The new technique has been verified using industry-recognized criteria, including applicability, system precision, accuracy, robustness, specificity, range, linearity, quantification limit, reagent stability, and detection limit. All the measured metrics were determined to be within acceptable limits using the criteria of the Worldwide Council for Harmonisation (ICH). In pharmaceutical labs, daclatasvir dihydrochloride may be analyzed qualitatively and quantitatively using the well-established RP-HPLC technique. Our study also highlights the need to evaluate the greenness of the method developed using a recognized tool ,i.e., Analytical Greenness Metrics (AGREE).