Force 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 photo stability 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 the degradation products involved a Enable C-18 G column 250x 4.6mm, 5μm. Injection volume of 20μL and a mobile phase composed of acetonitrile: potassium dihydrogen phosphate (pH3.5) in the ratio of 60:40v/v which was pumped through the column in isocratic mode at the flow rate of 1.0ml/min. The detection was carried out at 282 nm. The method was validated for linearity, range, precision, accuracy, specificity, selectivity and intermediate precision.