METHOD DEVELOPMENT AND VALIDATION OF NOVEL ANALYTICAL METHODS FOR DACLATASVIR IN BULK AND PHARMACEUTICAL FORMULATIONS USING UPLC TECHNIQUE

Shaik Mohammed Yusuf*, M. Purushothaman and A. Srikanth

ABSTRACT

A novel UPLC method proves to be simple, linear, precise, accurate, robust, rugged, and specific. A simple accurate, precise rapid isocratic RP-UPLC method development for the estimation of Daclatasvir is a tablet dosage form useful for routine quality control. The chromatographic system was carried on Acquity BEH C18 (50×3.0mm ×1.7μm id) using mobile phase consisting a mixture of 0.1% Orthophosphoric acid: Acetonitrile (60:40) v/v with detection of 248 nm. The retention time of Daclatasvir was found to be 1.190min. Calibration curve was linear over the concentration range of 50-150 μg/mL of Daclatasvir. The correlation coefficient for peak was found to be 0.9996. All the analytical validation parameters were determined and found in the limit as per ICH guidelines. UPLC methods were simple, highly sensitive, precise and accurate, suggesting that the developed methods are useful for routine quality control.

Keywords: Accurate, Daclatasvir, RP-UPLC, Acquity BEH column, ICH guidelines.