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Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR DACLATASVIR BY RP-HPLC METHOD

Prof. Pradip Patil* and Dr. M. Vamsi Krishna

ABSTRACT

A simple, rapid and accurate stability indicating RP-HPLC method was developed for the determination of Daclatsvir. The method was carried out using Column- Kromasil C18 (250×4.6mm, 5μ using ammonium acetate buffer and ACN (40:60, v/v), pH 4.7 as the mobile phase with detection at 335 nm and a flow rate of 1.0 ml/min. The retention time was found to be 6.69 min. The responses were linear in concentrations range of 1-160 μg/ml with correlation coefficient of 0.999. The method was statistically validated for accuracy, precision, linearity, and robustness.

Keywords: Daclatasvir, RP-HPLC Methods, Validation.


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