Abstract
A new simple accurate precise RP-HPLC method for the quantitative determination of Daclatasvir was developed and validated as per ICH guidelines for the parameters like accuracy precision robustness repeatability LOD and LOQ. Daclatasvir is a direct-acting antiviral agent against Hepatitis C Virus HCV used for the treatment of chronic HCV genotype 1 and 3 infection. It is marketed under the name DAKLINZA and in daily oral tablets as the hydrochloride salt form. The drug was injected into Denali C8 250mm4.6mm 5micro maintained at ambient temperature and effluent monitored at 304 nm. Different mobile phase compositions were trailed out of which the mobile phase consisting of 0.01N KH2 PO4 Acetonitrile in the ratio of 5050 VV was selected as optimized because it has given sharp peak with good resolution. The flow rate was maintained at 1.0 mlm. The calibration curve for Daclatasvir was linear from 15-90 microgml r2 for Daclatasvir0.999. The proposed method was adequate sensitive reproducible accurate and precise for the determination of Daclatasvir in bulk and pharmaceutical dosage forms.
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