HPLC手性流动相添加剂法拆分马来酸氨氯地平

Enantiomeric Resolution of Amlodipine Maleate by HPLC with Mobile Phase Additives

摘要: 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 20 mmol·L-1 SBE-β-CD 的 10 mmol·L-1磷酸盐缓冲液-乙腈(75∶25)，pH 5.0，柱温30.0 ℃，流速为1.0 mL·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。

Abstract: OBJECTIVE To develop an HPLC method with a chiral mobile phase additive for the enantiomeric separation of amlodipine maleate. METHODS Main influences of the type and concentration of the chiral mobile phase additive, the aqueous phase pH value, the ratio of organic modifiers, and column temperature on the chiral resolution of amlodipine maleate were investigated. RESULTS The resolution 2.08 was achieved when a C18 column was used at 30℃ with the mobile phase of acetonitrile-water (containing 20 mmol·L-1 SBE-β-CD, 10 mmol·L-1 phosphate buffer, pH 5.0) (25:75) at the flow rate of 1.0 mL·min-1. CONCLUSION Amlodipine maleate enantiomers can be separated baseline on C18 column.