不同厂家色谱柱对注射用氢化可的松琥珀酸钠与相关物质分离效果的考察

目的:比较不同厂家色谱柱对注射用氢化可的松琥珀酸钠与相关物质的分离效果,并筛选出适用于注射用氢化可的松琥珀酸钠分析的色谱柱。方法:以不同配比的磷酸盐缓冲液(pH 5.0)和甲醇为流动相,流速1.0 mL.min-1,检测波长为242nm。结果与结论:通过调整流动相的配比,Kromasil填料的色谱柱均可使17-氢化可的松琥珀酸钠、21-氢化可的松琥珀酸钠、游离氢化可的松及其他有关物质得到良好分离,且各峰的相对保留时间均符合中国药典的要求。

Suggestion and evaluation of HPLC columns from different manufacturers for the separation of hydrocortisone sodium succinate for injection

Objective: To made a comparison of columns between different types for separation of hydrocortisone sodium succinate for injection and put forward project.Methods: The mobile phase was phosphate buffer(pH 5.0)-methanol(57∶ 43) or(49∶ 51) at a flow rate of 1.0 mL·min-1,and the detection wavelength was 242 nm.Result and Conclusion: It had been shown that columns of Kromasil could be successfully applied to separate 17-hydrocortisone sodium succinate,21-hydrocortisone sodium succinate,hydrocortisone and other related substances after appropriately adjusting the proportion of the same mobile phase.