Analytical method development and validation for the estimation of DACLATASVIR in bulk and pharmaceutical dosage form using RP-HPLC
Keywords:
Daclatasvir, RP-HPLC, Reliable, Validation, Assay, Hepatitis, IsocraticAbstract
A simple, precise, accurate and linear reverse phase isocratic HPLC was developed and validated for the
determination of Daclatasvir in bulk and tablet dosage forms. Method development was carried out on Zorbax
Eclipse XDB-C18 isocratic column, (250mm × 4.6mm, particle size 5μ, maintained at ambient temperature).
The mobile phase was a mixture of 0.01M Potassium dihydrogen orthophosphate and Acetonitrile (15:85), with
apparent pH of 2.5 and the flow rate was set at 1.0ml/min and UV detection at 284nm. The statistical analysis
shows that the method was found to be accurate, reliable, simple and reproducible. The proposed method was
successfully applied for the quantitative determination of Daclatasvir in bulk form and could be used for routine
analysis with phenomenal accuracy and precisions.
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