[Enantiomeric separation of azelnidipine by high performance liquid chromatography with chiral stationary phase]

A high performance liquid chromatographic (HPLC) method was established for the enantiomeric separation of azelnidipine. Baseline chiral separation of azelnidipine was achieved under normal-phase chromatographic mode using the Chiralpak AD-H chiral column (250 mm x 4.6 mm, 5.0 microm, Daicel). The influences of the nature of chiral stationary phase, form of the mobile phase, and column temperature on the enantiomeric separation were studied. The optimized chromatographic conditions were hexane-isopropyl alcohol (90 : 10, v/v) as the mobile phase with a flow rate of 0.8 mL/min and detection at the wavelength of 254 nm. The column temperature was set at 20 degrees C. The resolution of 3.3 for azelnidipine was achieved under the above chromatographic conditions. The method is simple, rapid and with good reproducibility.