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目的建立HPLC-手性流动相添加剂法拆分马来酸氨氯地平。方法采用C18柱考察了手性添加剂种类及浓度、水相pH值、有机改性剂比例、柱温等对马来酸氨氯地平对映体拆分分离度的影响。结果流动相为含20mmol·L-1SBE-β-CD的10mmol·L-1磷酸盐缓冲液-乙腈(75∶25),pH5.0,柱温30.0℃,流速为1.0mL·min-1时,分离度可达到2.08。结论马来酸氨氯地平对映体在C18柱上得到了基线分离。
Objective To establish HPLC-chiral mobile phase additive method for the separation of amlodipine maleate. Methods The effects of the type and concentration of chiral additives, the pH value of aqueous phase, the ratio of organic modifiers and the column temperature on the separation and resolution of amlodipine maleate enantiomers were investigated by C18 column. Results The mobile phase consisted of 10 mmol·L-1 phosphate buffer-acetonitrile (75:25) containing 20 mmol·L-1 SBE-β-CD, pH 5.0 and the column temperature was 30.0 ℃ with a flow rate of 1.0 mL · min-1 , Resolution can reach 2.08. Conclusion Enantiomer of amlodipine maleate was baseline separated on C18 column.