高效毛细管电泳法用于环丙沙星原料药的杂质限量分析

Impurity limit test of raw material of ciprofloxacin by high performance capillary electrophoresis

目的 :建立环丙沙星杂质限量检查的高效毛细管电泳 ( HPCE)方法。 方法 :通过 p H值、进样时间及其他电泳条件的考察 ,确定检测环丙沙星及其杂质的 HPCE优选方法 ,并对该方法进行考察。结果 :方法精密度 RSD为 0 .2 3% (迁移时间 )和 2 .49% (峰面积 ) ;检测限为 1.2 1μmol/ L。杂质含量与样品溶液稀释保持一致。 结论 :HPCE法可成功地用于环丙沙星原料药的杂质限量分析。

Objective: To develop a high performance capillary electrophoresis(HPCE) method for the impurity limit test of raw material of ciprofloxacin. Methods: An optimal method was established by studying on pH value, sampling time and other electrophoretic conditions. Results: The RSD of migration time was 0.23% and of the peak area was 2.49%. The limit of detection was 1.21 μmol/L. The impurity profile and content was consistent with the dilution of sample concentration. Conclusion: HPCE method proves to be suitable for impurity limit test of raw material of ciprofloxacin. [