Volume :

5

Issue :

1

Abstract :

The RP- HPLC method was developed and validated for the determination of Dabigatran Etexilate Mesylate (DEM) in bulk form. The chromatography was carried out on Unisol C18 (4.6 × 150 mm, 3μm) using a mobile phase of methanol and ammonium acetate buffer in the ratio of 90:10, at a flow rate of 1 ml/minute. The analytes were monitored at 226 nm using a PDA detector. The retention time of the DEM was 2.52 min. The method was linear in the concentration range of 20-100 µg/ml with a correlation coefficient of 0.999. The method was validated as per ICH guidelines.