首次建立了一种灵敏、简便、准确的采用手性配位交换RP-HPLC与UV联用检测盐酸安妥沙星中对映体杂质的方法.以C18为固定相,含20mmol/LL-异亮氨酸和5mmol/L硫酸铜的水溶液为手性流动相添加剂,手性流动相添加剂-醇(80:20)为流动相，检测波长为297nm,流动1.0ml/min.非手性固定相ODS色谱柱可在10min内将两对映体良好分离,方法灵敏,精确.%A sensitive, simple and accurate method for enantiomeric impurity determination of antofloxacin hydrochloride was developed by chiral ligand-exchange RP-HPLC with UV detection. The C18 stationary phase additive was made up of 20mmol/L L-isoleucine mixed with 5mmol/L CuSO4 in water.Mobile phase consisted of the solution of chiral mobile phase additive-methanol (80 : 20). The detector wavelength is 297nm. The flow-rate of mobile phase was 1.0ml/min. The achiral ODS column offers good separation of the two enantiomers in less than 10min. The method provides a high sensitivity and good precision.
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