Development & validation of RP-HPLC method for estimation of Dabigatran etexilate mesylate from capsule dosage form

An accurate, sensitive and rapid RP-HPLC method has been developed and validated for the estimation of Dabigatran etexilate mesylate from capsule Dosage form. The separation was achieved by a Zorbax C18 column (100mm X 4.6mm, 3.5μm) in isocratic mode, with mobile phase comprises of Acetonitrile : Water in proportion of 70:30 v/v. The flow rate of mobile phase was 1.0ml/min and detection was done at 225nm wavelength. The retention time of Dabigatran etexilate mesylate was 3.0 min. The calibration curve was found to be linear within the concentration range of 20μg/ml to 100μg /ml. The regression data for calibration curve shows good linear relationship with r2= 0.998. The method was validated as per the ICH guidelines. Moreover, the proposed analytical method can be used for routine analysis of Dabigatran etexilate mesylate in quality control labs.