Author(s): Mrinalini CDamle, Rupesh A Bagwe
A simple, selective and rapid stability indicating reverse phase high performance liquid chromatographic (RP - HPLC) method for the estimation of Dabigatran Etexilate has been developed and validated. Analyte was resolved on a Neosphere C 8 (150mm X 4.6 mm) column. The mobile phase consisted of Methanol: Phosphate Buffer (0.01M pH 3) in the ratio of 60:40 ʋ / ʋ and sonicated to degas. It was delivered at a flow rate of 1ml/min at ambient temperature and the retention time was about 4.4±0.05 minutes. Studies were performed on an HPLC system equipped with a PDA detector at 225nm. The drug was subjected to stres s condition of hydrolysis (acid, base, neutral), oxidation, photolysis and thermal degradation. The calibration curve was linear over the concentration range of 1 - 5 μ g/ml (R=0.999). The limit of detection for Dabigatran Etexilate was found to be 0.014 μ g/ml and the quantification limit was about 0.040 μ g/ml. The accuracy of the method was established based on the recovery studies. The proposed method is applicable to the routine analysis of Dabigatran Etexilate .