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目的采用磺丁基醚-β-环糊精(SBE-β-CD)作为手性流动相添加剂,以反相高效液相色谱技术(RP-HPLC),建立了磷酸氯喹、马来酸氯苯那敏、盐酸维拉帕米3个含N碱性药典品种对映体在RP-HPLC系统中的拆分方法并探讨其机制。方法色谱柱为Alltima C18(4.6 mm×250 mm,5μm);流动相:乙腈-水(含磺丁基醚-β-环糊精、磷酸二氢钠,用磷酸调pH值至2.5);检测波长:332、264、278 nm;流速:0.8 mL.min-1;柱温:25℃。结果磷酸氯喹、马来酸氯苯那敏、盐酸维拉帕米可在上述色谱条件下分别与其对映体得到分离,同时考察手性流动相添加剂的种类和浓度、pH、缓冲盐的种类和浓度、有机相的种类和比例、柱温对药物对映体拆分效果的影响,选择了最佳的手性分离条件并对其分离机制作了探讨。结论 SBE-β-CD作为一种手性添加剂,用于手性流动相RP-HPLC,可拆分含N碱性的手性药物,其手性分离效果明显优于天然环糊精(β-CD)及衍生化的中性环糊精(HP-β-CD)。
OBJECTIVE To establish a method for the determination of chloroquine phosphate and chlorobenzene chlorobenzene by RP-HPLC using sulfobutylether-β-cyclodextrin (SBE-β-CD) as a chiral mobile phase additive. Namin, and Verapamil Hydrochloride in RP-HPLC System and Their Mechanisms. Methods The column was Alltima C18 (4.6 mm × 250 mm, 5 μm). The mobile phase consisted of acetonitrile-water (containing sulfobutyl ether-β-cyclodextrin and sodium dihydrogen phosphate, adjusted to pH 2.5 with phosphoric acid) Wavelength: 332, 264, 278 nm; Flow rate: 0.8 mL.min-1; Column temperature: 25 ° C. Results Chloroquine phosphate, chlorpheniramine maleate and verapamil hydrochloride were separately separated from their enantiomers under the above chromatographic conditions. The types and concentrations of chiral mobile phase additive, pH, buffer salts and Concentration, the type and proportion of the organic phase and the column temperature on the resolution of the enantiomers of the drug, the optimum conditions of chiral separation were selected and their separation mechanism was discussed. Conclusion As a chiral additive, SBE-β-CD can be used in chiral mobile phase RP-HPLC to separate chiral drugs containing N-basicity. The chiral separation effect of SBE-β-CD is obviously better than that of natural cyclodextrin (β- CD) and derivatized neutral cyclodextrin (HP-β-CD).