METHOD DEVELOPMENT AND VALIDATION OF DACLATASVIR TABLET DOSAGE FROM
Shivrani Nimbokar*, Ravindra L. Bakal and Jagdish Manwar
ABSTRACT
A Novel simple, precise and economical high performance liquid chromatographic method has been developed and validated for the analysis of antiviral drug Daclatasvir in pure form and in tablet dosage form as well. The chromatographic analysis was performed on HPLC 30000 series analytical technologies ltd. Detector UV 3000 M. Column- cosmosil C18 (250mm*4.6ID, particle size: 5micron) Mobile phase methanol:water (60:40) detection wavelength 230nm, flow rate 1ml/min, Temperature – ambient, Sample size-5.0?g were selected to develop an accurate method. The flow rate of mobile phase was maintained at 1ml/min and the response was monitored at 230nm with a run time of 10 min. the volume. The volume of injection loop was20?l.The developed method was validated as per ICH guidelines; it was precise, accurate and robust. The calibration curve of Daclatasvir was linear in range og 10- 50?g/ ml with a correlation coefficient> 0.997.
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