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242 nm。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。

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.

1 ChP(中国药典).2010.Vol Ⅱ(二部):552
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5 BAI Xue-yan(白雪艳),WANG Wei(王伟),LI Peng(李鹏).HPLC determination of related substances in hydrocortisone succinate sodium for injection(sterile powder)[HPLC法测定注射用氢化可的松琥珀酸钠(无菌粉)有关物质].Tianjin Pharm(天津药学),2009,21(6):10
6 YIN Qin-hong(殷勤红),ZHU Yan-qin(朱艳琴),FENG Pu-chun(冯朴纯).Chromatogram conditions for determination of hydrocortisone sodium succinate for injection by HPLC(高效液相色谱法测定注射用氢化可的松琥珀酸钠含量的色谱条件考察).Chin J Spectrosc Lab(光谱实验室),2010,27(6):2246