Abstract

A new and stability indicating liquid chromatographic method for the determination of dabigatran in bulk drug and pharmaceutical dosage form.

Author(s): M.Balaji , Pawanjeet J.Chhabda, V.Srinivasarao, K.M.Ch.Appa Rao, K.Ramakrishna

The objective of the current study was to develop a validated, simple, precise, stability indicating reverse phase HPLC method for the determination of Dabigatran etexilate mesylate in bulk drug and dosage form. LC separationwas achieved gradientmode on a Zorbax SB C18 (4.6x150) mm, 3.5 µm column using mobile phase containing solution A (2.72g of potassium dihydrogen phosphate in 1000 ml of water) PH 4.5 with ortho phosphoric acid solution B (acetonitrile) at flow rate 1.0 ml/min. The method employed a linear gradient elution and detection wavelength was set at 220 nmand temperature was 25°c. The retention time was 8.65min and linearity was observed in the concentration range of 24-180 µg/ml with correlation coefficient of 0.9999. The percentage relative standard deviation in accuracy and precision studies was found to be less than 2%. The method was successfully validated as per International Conference on Harmonization (ICH) guidelines. Dabigatran undergoes degradation under acidic, basic, oxidation, dry heat and photolytic conditions, degradation impurities did not interfere with the retention time of Dabigatran, and assay method is thus stability indicating.