【摘要】 建立蛋白酶抑制剂甲磺酸加贝酯原料药的有关物质分离检测及其含量测定方法。采用反相离子对色谱法,色谱柱为ODS柱;流动相为乙腈 辛烷磺酸钠缓冲液(pH 值 3.5)(40∶60),流速为1.0 ml/min;含量检测波长为236 nm,有关物质检测波长为258 nm。以此建立的色谱方法使有关物质与主药分离良好,甲磺酸加贝酯在12.5~125.0μg/ml内线性关系良好,平均回收率为99.75%,RSD为0.6%。方法简便、准确,可用于甲磺酸加贝酯有关物质的检查及含量测定。更多还原

【Abstract】 To establish a RPIC method for isotation of related substances and determination of gabexate mesylas, reversed phase RPIC was carried out on ODS column. The mobile phase was constituted by acetonitrile sodium camphorsulfonate buffer solution (pH 3.5) (40∶60). The flow rate was 1.0 ml/min . The detective wavelength for dertermination was 236 nm . The detective wavelength for related substances was 258 nm . Under optimum chromatographic conditions, the related substances and gabexate mesylas were completely separated. A good linearity was observed for gabexate mesylas in the range of 12.5~125.0 μg/ml. The average recovery of gabexate mesylas was 99.75% with RSD 0.6%. The method is simple and accurate, and can be used in the quality control of gabexate mesylas.更多还原