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目的:建立拆分新药尤利沙星对映异构体的HPLC手性流动相添加剂法。方法:通过探讨流动相pH、手性添加剂种类及浓度对手性拆分的影响,确定流动相为甲醇-异亮氨酸手性溶液(取L-异亮氨酸1.04g和硫酸铜1.0g溶于1000mL水中)(17∶83),在C18(250mm×4.6mm,5μm)柱上拆分尤利沙星对映体,检测波长为330nm,柱温为40℃。结果:两对映体分离良好,分离度在4.0以上,左旋体及右旋体检测限均为5ng。结论:本方法分离度好,简便易行,比手性固定相经济,可用于尤利沙星光学纯度的质量控制。
OBJECTIVE: To establish a HPLC chiral mobile phase additive method for the separation of the enrofloxacin enantiomers of new drugs. Methods: The mobile phase consisted of methanol-isoleucine solution (1.04 g L-isoleucine and 1.0 g L-Sulfate solution) were determined by studying the effect of mobile phase pH and type and concentration of chiral additives on chiral resolution. In 1000 mL water) (17:83), the enantiomers of the elishafonate were resolved on a C18 (250 mm × 4.6 mm, 5 μm) column with a detection wavelength of 330 nm and a column temperature of 40 ° C. Results: The separation of two enantiomers was good with the resolution above 4.0. The limits of detection of both enantiomers were about 5ng. Conclusion: The method has good separation, is simple and easy to operate, and is more economical than the chiral stationary phase. It can be used for the quality control of the optical purity of the.