建立了阿折地平对映体的高效液相色谱拆分方法.采用Chiralpak AD-H (250 mm×4.6 mm,5.0 μm,Daicel公司)手性色谱柱在正相条件下直接拆分阿折地平对映体,考察了固定相种类、流动相组成及柱温等对阿折地平对映体分离的影响.确定了最佳的拆分条件:流动相为正己烷-异丙醇(90∶10,v/v),流速为0.8 mL/min,检测波长为254 nm;柱温为20 ℃;在此条件下阿折地平对映体的分离度为3.3.该法简单快速,重现性好.
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×4.6 mm,5.0 μm,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 ℃.The resolution of 3.3 for azelnidipine was achieved under the above chromatographic conditions.The method is simple,rapid and with good reproducibility.
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