A NEW RP-UPLC METHOD DEVELOPED FOR THE SIMULTANEOUS DETERMINATION OF TELMISARTAN AND AZELNIDIPINE IN DOSAGE FORMS

A new, precise, and sensitive ultra-performance liquid chromatography method for simultaneous estimating Telmisartan and Azelnidipine in bulk and tablet dosage form was developed and validated. The chromatographic separation was achieved by using the HSS C18 (100 x 2.1 mm, 1.8m) column. A mixture of buffer and ACN (70:30 v/v) was pumped through the column at a flow rate 0.3 mL/min. The temperature was maintained at 30 °C, eluents were monitored at 260 nm, and Telmisartan and Azelnidipine retention time was 1.636 min. and 1.153 min. The method obeys the Beer-Lambert’s law in the range of 20-120 μg/mL (Telmisartan) and 2-12 μg/mL (Azelnidipine) with regression equations as y = 15673x + 11440 and y = 16761x + 597.17 respectively. Assay (%) was obtained as 99.94 % w/w and 98.96 % w/w for Telmisartan and Azelnidipine, respectively. The force degradation studies were performed under conditions like acidic, alkaline, oxidation, thermal, photolytic, and water. According to ICH guidelines, the methods were validated for system suitability, linearity, accuracy, precision, sensitivity, robustness, LOD, and LOQ. They can be conveniently used for the regular quality control analysis of the drugs in bulk and tablets.