Development and validation of In-vitro dissolution test using RP-HPLC Analysis for simultaneous estimation of Azelnidipine and Telmisartan in a fixed-dose combination

The present analytical study aims to develop and validate the RP-HPLC method for dissolution of Azelnidipine (AZE) and Telmisartan (TEL) in fixed-dose combination tablets (8 mg/40 mg) and also to demonstrate that the test method used, is suitable for its intended purpose as per ICH guidelines. The protocol developed utilizes Inertsil ODS 3V, C18 column 150 × 4.6 mm, 5 μm particle sizes, column oven temperature 40°C with a flow rate of 1.5 mL/min. The volume of injection was kept at 10 μL and run time 11.0 minutes at 254 nm using Acetonitrile and buffer as mobile phase in gradient mode. Thus developed method after validating on different parameters was found to be complying with system suitability, specificity, precision, intermediate precision, accuracy, linearity, robustness, and solution stability found to meet the predetermined acceptance criteria.