Analytical method development and validation for the estimation of Declatasvir in bulk and pharmaceutical dosage form using RP - HPLC
Keywords:
Daclatasvir, RP-HPLC, reliable, validation, assay, hepatitis, isocratic.Abstract
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,
(250 mm × 4.6 mm, particle size 5 µ, 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 1.0 ml/min and UV
detection at 284 nm. The statistical analysis shows that the method was found to be accurate, reliable, simple and reproducible.
The accuracy of the method was proved. 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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