DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING RP-HPLC METHOD FOR ESTIMATION OF DABIGATRAN ETEXILATE

Abstract

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 C8 (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 stress condition of hydrolysis (acid, base, neutral), oxidation, photolysis and thermal degradation. The calibration curve was linear over the concentration range of 1-5μg/ml (R=0.999). The limit of detection for Dabigatran Etexilate was found to be 0.014 μg/ml and the quantification limit was about 0.040 μg/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.