摘要
目的:采用高效液相色谱方法测定葡甲胺中有关物质。方法:采用强酸性阳离子交换基团键合全多孔不规则形硅胶固定相色谱柱(SCX),流动相为三氟乙酸-甲酸-水(0.05∶0.3∶100),流速0.6 mL.min-1,示差折光检测器,柱温35℃;并采用液相质谱方法对该系统进行分离度检测。结果:使用该系统能够使葡甲胺主峰与有关物质完全分离,分离度均大于2.0;最低检出限为10μg.mL-1。结论:本方法简便、准确、稳定,专属性强,能够对葡甲胺中的有关物质进行有效检测。
Objective：Study on determination of the related substances in Meglumine by HPLC. Method： Using Irregular or spherical totally porous silica gel having a chemically bonded strongly acidic ation-exchange （SCX） ;considering TFA-formic acid-water（ 0. 05： 0. 3：100 ）, and the flow rate is 0.6 mL ·min^-1, differential refractive index detector ; Temperature ： 35 ℃ ; determination of the resolution of the system by HPLC-MS. Result ：The peak of related substances vs Meglumine can be separated colnpletly, resolution is greater than 2. 0 ;the limit of operation is 10 μg · mL^-1. Conclusion： The method of operation is so simple, accurate, stable, specific that it can be used to determine the related substances in Meglumine.
出处
《中国药品标准》
CAS
2011年第3期184-187,共4页
Drug Standards of China
