Received: April 12, 2023 Accepted: April 14, 2023 Published: April 14, 2023
A novel, precise, and sensitive ultra-performance liquid chromatograph method for simultaneous estimation of anti-hypertensive drugs in bulk and tablet dosage form was developed and validated. The chromatographic separation was achieved by using 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 flowrate 0.3 mL/min. Temperature was maintained at 30 °C, eluents were monitored at 260 nm and retention time of Telmisartan and Azelnidipine were found to be 1.636 min. and 1.153 min. Themethod obeys the Beer-Lambert’s law in the range of 20-120 μg/mL (Telmisartan) and 2-12μg/mL (Azelnidipine) with regression equations as y = 15673x + 11440 and y = 16761x +597.17 respectively. The assay (%) was obtained for Telmisartan and Azelnidipine 99.94 % w/wand 98.96 % w/w respectively. The force degradation studies were performed under differentconditions like acidic, alkaline, oxidation, thermal, photolytic and water. The methods werevalidated for system suitability, linearity, accuracy, precision, sensitivity, robustness, LOD andLOQ according to ICH guidelines and can be conveniently used for the regular quality controlanalysis of the drugs in bulk and tablets.
Keywords: Anti-hypertensive drugs, RP-UPLC, ICH, Validation, Forced degradtion