格列苯脲有关物质检查中色谱柱的选择.PDFVIP

第 32 卷 第 期 河 北 工 业 科 技 Vol. 32, No. 2015 年 月 Hebei Journal of Industrial Science and Technology 2015 文章编号:1008-1534(2015)00-0001-00 格列苯脲有关物质检查中色谱柱的选择 孙 义，周学辉，王志英，曾玉香 （天津渤海职业技术学院，天津 300402 ） 摘 要 ：各国药品标准越来越多使用高效液相色谱法作为含量测定和有关杂质检查的方法。高效液相色 谱法的关键是起分离作用的色谱柱，但色谱柱种类繁多。由于色谱柱选择性的差异，使药典在执行过程 中很难保证方法的重现性，因此能否选择出合适的色谱柱成为色谱分析的关键。以降糖药格列本脲有关 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 ，可以选出需要的色谱柱。 关键词： ;色谱分析；色谱柱选择；色谱柱分类；格列本脲；高效液相色谱法；有关物 质检查 中图分类号：O65 文献标志码：A doi:10.7535/hbgykj.2015yx Selection of columns for the test on related substances of Glibenclamide SUN Yi, ZHOU Xuehui, WANG Zhiying, ZEN Yuxiang (Tianjin Bohai Vocational Technological College, Tianjin 300402, China) Abstract: High performance liquid chromatography(HPLC) has been widely used in the pharmaceutical standard for content determination and test on related substances . There are many kinds of columns which are the heart of HPLC. Yet even the same filler can not give us the same separation effect with different columns selectivity, therefore, it is important to choose the suitable HPLC column for carrying out an experiment. The separation of glibenclamide from the respective impurities was taken for example, according to EP7.0,five kinds of column were choosen and classified on the basis of some column classification systems. The tests for system suitability on related substances were completed using five columns ,the column classification systems were compared for the selection of a suitable column in accordance with the testing results. The analysis result shows that the different column classification