An RP-HPLC Method Performance and Validation for Azelnidipine Measurment and Metoprolol Succinate Within a Synthetic Mixture Download PDF

Current research paper describes the RP-HPLC method for the determination of Azelnidipine and Metoprolol Succinate from the synthetic mixture. Azelnidipine is a Calcium channel blocker and Metoprolol Succinate is a Beta blocker. Both drugs are from the Anti-Hypertensive class. The present analytical method was developed on Shimadzu HPLC LC2010 which includes a UV-VIS detector and binary gradient system. Separation of the component was achieved on Hibar ODS C₁₈ 5 µ column (250 x 4.6 mm) at ambient temperature in isocratic mode with a mixture of Methanol: water (70:30 v/v) as mobile phase (pH – 3.0) at a flow rate of 1.0 ml/min with UV detection at 230 nm. The method shows a linear response in the range of 8-40 µg/ml of Azelnidipine and 25-125 µg/ml of Metoprolol Succinate. The devised approach was successfully used to determine azelnidipine and metoprolol succinate from a synthetic combination and was verified in following ICH Q2 R1 requirements.