Author(s): P radeep G Shelke, AV Chandewar
Dabigatran Etexilate Mesylate was subjected to different ICH recommended stress conditions. Degradation of drug occurs almost in all conditions (hydrolytic, oxidative and photolytic) while mild degradation was seen with thermal stress. A validated stability - indicating HPLC method was developed for the analysis of drug in presence of its degradation products. The stressed samples of drug were analyzed using Kinetex C - 8 column (5μ, 250×4.6 mm) column using a mobile phase composed of methanol: water, which was delivered initially in the r atio of 70:30 (v/v) for 1 min, then changed to 90:10 (v/v) for next 9 min and finally equilibrated back to initial composition 70:30 (v/v) from 11 to 20 min. The flow rate was maintained at 1.0 ml/min and detection was carried out at 230 nm using 996 PDA d etector. The method was validated in terms of linearity, accuracy, precision specificity and selectivity.