Stress Degradation Studies of Telmisartan and Hydrochlorothiazide and Development of Validated Stability Indicating Method

Telmisartan and Hydrochlorothiazide were subjected to different ICH prescribed stress conditions like acidic, alkaline, oxidation, reduction, thermal and photostability condition and found that degraded peaks did not interfere with the peaks of drug under the study. A stability indicating HPLC method was developed for analysis of the drug in the presence of degradation products involved a Enable C-18 G column 250x 4.6mm, 5 μm. Injection volume of 20 μL and a mobile phase composed of acetonitrile: potassium dihydrogen phosphate (pH 3.5) in the ratio of 60:40 v/v, which was pumped through the column in isocratic mode at the flow rate of 1.0 ml/min. The detection was carried out at 282 nm. The method was validated for linearity, range, precision, accuracy, specificity, selectivity and intermediate precision. Moin Shakeb 1 and S. B. Puranik 2