Development and Validation of an RP-HPLC Method for Simultaneous Quantification of Azelnidipine and Metoprolol Succinate in Synthetic Mixtures

This study outlines an RP-HPLC technique for quantifying azelnidipine and metoprolol succinate in a synthetic mixture. Azelnidipine, a calcium channel blocker, and metoprolol succinate, a beta-blocker, are both used for the management of hypertension. The method was optimized using a Shimadzu HPLC LC2010 system, equipped with a UV-VIS detector and a binary gradient system. A Hibar ODS C18 5 µm column (250 x 4.6 mm) was used for separation in isocratic mode, with a mobile phase consisting of methanol and water (70:30 v/v, pH 3.0), at a flow rate of 1.0 ml/min and detection set at 230 nm. The method demonstrated linearity for azelnidipine in the range of 8-40 µg/ml and for metoprolol succinate between 25-125 µg/ml. This developed method successfully determined both drugs in synthetic mixtures and followed the ICH Q2 R1 guidelines for method validation.