RP-HPLC Method for Estimation of Daclatasvir in Bulk and Tablet Dosage Form

[摘要] 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 (250mm*4.6mm 5µ); 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 50:50 V/V was selected as optimized because it has given sharp peak with good resolution. The flow rate was maintained at 1.0 ml/m. The calibration curve for Daclatasvir was linear from 15-90 µg/ml (r2 for Daclatasvir=0.999). The proposed method was adequate, sensitive, reproducible, accurate and precise for the determination of Daclatasvir in bulk and pharmaceutical dosage forms. 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 (250mm*4.6mm 5µ); 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 50:50 V/V was selected as optimized because it has given sharp peak with good resolution. The flow rate was maintained at 1.0 ml/m. The calibration curve for Daclatasvir was linear from 15-90 µg/ml (r2 for Daclatasvir=0.999). The proposed method was adequate, sensitive, reproducible, accurate and precise for the determination of Daclatasvir in bulk and pharmaceutical dosage forms.

[学科分类] 药学、药理学、毒理学（综合）

[关键词] Daclatasvir;Linearity;Accuracy;Precision;Validation;RP-HPLC