反相高效液相色谱梯度洗脱法测定厄他培南钠的含量和有关物质  

Determination of ertapenem sodium and its related substances by RP-HPLC gradient elution method

作　　者：史颖 谢赞 张雅然 王婀娜 朱素杰 

机构地区：[1]石药集团中奇制药技术(石家庄)有限公司,石家庄050035

出　　处：《中国抗生素杂志》2012年第10期776-778,I0002,共4页Chinese Journal of Antibiotics

基　　金：科技部"十一五"重大新药创制(NO.2010ZX09401-402)

摘　　要：目的建立反相高效液相色谱梯度洗脱法测定厄他培南钠含量及有关物质的方法。方法采用Inertsil ODSC18柱（250mm×4．6mm，51μm），0．01mol／L乙酸铵溶液为流动相A，乙腈为流动相B，梯度洗脱，流速为1．0mL／min，柱温25℃，检测波长为230nm。结果厄他培南在0．17～0．87mg／mL范围内线性关系良好，r=0．9997，最低检测浓度为17ng／mL，嗯嗪酮、Pro—maba、开环降解物和二聚物等有关物质在该色谱条件下均分离良好。结论本法重现性好，专属性强，可用于测定厄他培南钠的含量和有关物质。Objective To develop a RP-HPLC gradient elution method for determination of ertapenem sodium and its related substances. Methods The gradient elution was used with a flow rate of 1.0mL/min. The column was Inertsil ODS C18 （250mm×4.6mm, 5μm）. Mobile phase A： 0.01mol/L ammonium acetate solution; mobile phase B： acetonitrile. The column temperature was 25℃. The detection wavelength was 230nm. Results The calibration curve was linear in the range of 0.17-0.87mg/mL （r=0.9997）. The limit of detection of ertapenem was 17ng/mL. The related subatances in ertapenem sodium such as oxazinone, Pro-maba, ring-opend hydrolysis product and dimers were separated successfully. Conclusion This method with good reproducibility and specificity, is suitable for the determination of ertapenem sodium and its related substances.

关 键 词：厄他培南钠 含量 有关物质 反相高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]