RP-HPLC测定利福昔明的含量及有关物质

Determination of Rifaximin and its related substances by RP-HPLC

目的 建立测定利福昔明含量及有关物质的方法。方法 采用C18色谱柱 (5 μm ,15 0mm× 4.6mm) ,流动相为甲醇 -乙腈 - 0 .0 5mol·L-1磷酸二氢钾溶液 - 0 .5mol·L-1枸橼酸溶液 (5 0∶2 5∶2 0∶5 ) ,检测波长 2 5 4nm。结果 利福昔明在 5 0～ 2 0 0 μg·ml-1浓度范围内 ,峰面积与浓度呈良好的线性关系 (r=0 .9999) ,平均回收率为 99.9%。结论 所建方法简便 ,专属性及重复性好 ,可用于利福昔明的含量及有关物质的测定。

OBJECTIVE To establish a method for the assay of Rifaximin and its related substances.METHODS An RP-HPLC method was used with C 18 column(5 μm,150 mm×4.6 mm). The mobile phase was a mixture of methanol-acetonitrile-0.05 mol·L -1 monopotassium phosphate-0.5 mol·L -1 citric acid(50∶25∶20∶5).The detect wavelength was set at 254 nm.RESULTS The linear range of Rifaximin was 50-200 μg·ml -1 (r=0.9999).The average recovery was 99.9%. CONCLUSION This method is simple, selective and reproducible for the assay of Rifaximin and its related substances.