Abstract

METHOD DEVELOPMENT AND VALIDATION FOR ASSAY OF DABIGATRAN ETEXILATE MESYLATE IN PHARMACEUTICAL DOSAGE FORM BY HPLC

*Dr. A. Sambasivarao M. S.

ABSTRACT

A new HPLC method was developed and validated for the determination of Dabigatran Etexilate Mesylate (DEM), in tablet dosage form. The chromatographic quantification and qualification was achieved on a XTerra C18 (4.6 x 150mm, 5 m) or equivalent with a mobile phase combination of Ph4.5 0.1%TFA buffer and Acetonitrile in isocratic mode in 45:55 ratio, employing flow rate of 1.0 ml/min, and the detection was carried out by using UV detector at 334 nm with total run time was 6 minutes. The retention time of DEM was found to be 2.163min. The performance of the method was validated according to the present ICH guidelines.

Keywords: RP-HPLC, Dabigatran Etexilate Mesylate (DEM).