Abstract

A simple, precise, accurate and rapid stability indicating High performance liquid chromatography method was developed and validated for the determination of Dabigatran etexilate in bulk and capsule dosage forms. Chromatographic separation was achieved by using Mobile phase "A"(phosphate Buffer pH4.5& Acetonitrile in the ratio 50:50) with Hypersil BDS C18 (150 × 4.6 mm, 5μm) as stationary phase. Diluent with composition of Acetonitrile and water in the ratio 80:20 is used for dilutions. Flow rate was optimised to 1.2 ml/min and effluents were monitored at 230 nm. The retention time was around 3.19. Linearity was observed over a concentration range of 9-113 μg/ml with correlation coefficient of 0.999.Stress conditions of degradation in acidic, alkaline, peroxide, thermal and UV radiation was studied and found that  Dabigatran etexilate  is sensitive to acidic and thermal comparative to other stress conditions. The method is validated as per ICH Guidelines and the results were well within the limits.