格列苯脲有关物质检查中色谱柱的选择

Selection of columns for the test on related substances of glibenclamide

高效液相色谱法作为含量测定和有关杂质检查的方法被越来越多地应用于各国药品标准中,色谱柱是高效液相色谱法的关键,但由于色谱柱种类繁多以及选择性的差异,导致药典在执行过程中很难保证检查方法的重现性,因此选择合适的色谱柱成为色谱分析的关键。以降糖药格列苯脲有关物质检查中色谱柱的选择为例,参照欧洲药典(EP7.0),对给出的5种色谱柱分别按照不同的分类方法进行分类,对5种色谱柱有关物质检查系统的适用性分别进行测试。根据测试结果得出的结论,分析比较了不同色谱柱分类方法对色谱柱选择所起的作用。分析结果表明,结合不同的色谱柱分类方法对色谱柱进行选择,可以选出适用的色谱柱。

High performance liquid chromatography（HPLC）has been widely used in the pharmaceutical standard for content determination and test of related substances.There are many kinds of columns which are the core of HPLC.Yet the same filler cannot assure the same separation effect with different columns,therefore,it is important to choose the suitable HPLC column to carry out an experiment.Taking the selection of columns in the separation of glibenclamide for example,according to EP7.0,five kinds of columns are chosen and classified on the basis of different column classification systems,the system suitability of the columns to related substances are tested,and based on the conclusion from the test result,the roles of the column classification systems in the selection of suitable column are compared.The analysis result shows that combining different column classification systems can help find the required column.