RP-HPLC method development and validation for quantification of daclatasvir dihydrochloride and its application to...

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Daclatasvir dihydrochloride is a key antiviral for Hepatitis C treatment.
• A validated pharmacopeial method for its quantification in pharmaceutical products is currently unavailable.

Purpose of the Study:

• To develop and validate a simple, rapid, precise, and accurate RP-HPLC method for daclatasvir dihydrochloride quantification.
• To establish a reliable method for quality control of daclatasvir dihydrochloride in pharmaceutical dosage forms.

Main Methods:

• Isocratic RP-HPLC using a Hypersil ODS-C18 column.
• Mobile phase: phosphate buffer (pH 3.5) and acetonitrile (60:40 v/v).
• UV detection at 308 nm, flow rate of 1.0 ml/min.

Main Results:

• The method demonstrated excellent linearity (R²=0.9993) over a wide concentration range (0.5-150%).
• Low limits of detection (LOD=0.005 μg/ml) and quantification (LOQ=0.01 μg/ml) were achieved.
• The method was successfully applied to assay and in-vitro dissolution studies of daclatasvir dihydrochloride tablets.

Conclusions:

• The developed RP-HPLC method is suitable for the quality control and estimation of daclatasvir dihydrochloride in pharmaceutical formulations.
• This validated analytical technique provides a valuable tool for ensuring the quality of Hepatitis C antiviral medications.