Author(s): Nadeem Ahmad Khan, Keyur Babubhai Ahir, Namrata Balram Shukla, Pooja Jairam Mishra
A simple and sensitive RP-HPLC method for the determination of dabigatran etexilate mesylate in pharmaceutical dosage formulation and in bulk has been developed and validated along with its stress degradation studies as recommended by ICH stress conditions. Degradation of dabigatran etexilate mesylate was observed almost in all stress conditions (hydrolytic, oxidative and thermal). A validated stability-indicating RP-HPLC method was developed for the determination of dabigatran etexilate mesylate in presence of its degradation products. The best separation was achieved using kromasil C18 (250 X 4.6 mm, 5 ?m particle size) analytical column at temperature 28°C using a mobile phase composed of HPLC grade methanol and 100 mM ammonium acetate buffer (pH 7.4) (85 : 15% v/v) in low pressure gradient mode. The flow rate was set at 1 ml/min and UV detection wavelength was 226 nm. The method was validated with respect to linearity, sensitivity, accuracy, precision, robustness and solution stability. The method was specific and it was observed that there was no interference with excipients. The validation results obtained from the analysis also reveals that the developed method is specific and selective. The retention time of dabigatran etexilate mesylate was found to be 4.95±0.2 min. The linearity was established over the concentration range of 2-10 ?g/ml with correlation coefficients 0.999. The method can be successfully employed for the determination of dabigatran etexilate mesylate in pharmaceutical dosage formulation and in bulk.