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目的:建立测定福沙匹坦二甲葡胺对映异构体的高效液相色谱方法。方法:用硅胶表面共价键合有直链淀粉-三(3,5-二甲苯基氨基甲酸酯)为填充剂(CHIRALPAK~IA,250 mm×4.5 mm,5μm);以正己烷-无水乙醇(90∶10)为流动相;检测波长为210 nm;流速为1.0mL·min~(-1)。结果:对照品浓度在1.03~15.47μg·mL~(-1)范围内线性良好(r=0.999 8),平均回收率为98.94%,RSD为0.63%,定量限浓度为1.77μg·mL~(-1),检测限浓度为0.531μg·mL~(-1)。结论:本方法专属性强、准确度高,可用于福沙匹坦二甲葡胺对映异构体的质量控制。
OBJECTIVE: To establish a high performance liquid chromatography method for the determination of oxadixine enantiomers. METHODS: Amylopectin-tris (3,5-dimethylphenylcarbamate) was covalently bonded to the surface of silica gel as a filler (CHIRALPAK ~ IA, 250 mm × 4.5 mm, 5 μm) The mobile phase was ethanol (90:10). The detection wavelength was 210 nm and the flow rate was 1.0 mL · min ~ (-1). Results: The linear range was 1.03 ~ 15.47μg · mL -1 (r = 0.999 8), the average recovery was 98.94%, the RSD was 0.63% and the limit of quantification was 1.77μg · mL ~ (-1) -1). The limit of detection was 0.531 μg · mL -1. Conclusion: The method is highly specific and accurate and can be used for the quality control of oxadixamine enantiomers.