Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF RANOLAZINE AND DRONEDARONE IN PHARMACEUTICAL DOSAGE FORM

*Prof. Tejas J. Sharma, Prof. Shubham P. Kokate, Rushikesh P. Tangade and Sanjivani A. Chankhore

Abstract

A simple, Accurate, Precise method was developed for the simultaneous estimation of Ranolazine and Dronedarone in pharmaceutical dosage form. Chromatogram was run through Water symmetry, 3.5 mm; 150 x 4.6 mm ID. Mobile Phase containing trifluoroacetic acid and acetonitrile (24:76) as a mobile phase was pumped through column at a flow rate of - 1.2 ml/min. temperature was maintained 300C. Optimized wavelength of Ranolazine and Dronedarone was 282 nm. Retention time of Ranolazine and Dronedarone were found to be 3.39min and 7.92min. % RSD of the Ranolazine and Dronedarone were found to be 1.11 and 1.66 respectively. LOD, LOQ values are obtained from equation of Ranolazine and Dronedarone were 2.02, 6.76 & 0.23, 0.76 respectively. linear regression observed for RZN and DRD. As resulted, they were y = 36923x + 52025 and y = 46667x - 68266, respectively.

Keywords: Method Development, Ranolazine, Dronedarone, RP-HPLC.