亚胺培南有关物质测定方法的优化  

Optimization of the HPLC method for determination of related substances in imipenem

作　　者：贾艳花[1] 彭洁[1] 罗嘉琳 李佩 丁子珊 洪建文[1] Jia Yanhua;Peng Jie;Luo Jialin;Li Pei;Ding Zishan;Hong Jianwen(Guangdong Institute for Drug Control,Guangzhou 510663)

机构地区：[1]广东省药品检验所,广州510663

出　　处：《中国抗生素杂志》2025年第3期344-350,共7页Chinese Journal of Antibiotics

基　　金：广东省药品监督管理局科技创新项目(No.2023TDB04);广东省医学科学技术研究基金项目(No.B2023235)。

摘　　要：目的优化亚胺培南有关物质的测定方法。方法采用C18色谱柱(Inertsil ODS-3,4.6 mm×250 mm,5μm);流动相A为pH7.3磷酸盐缓冲液-乙腈(99.3:0.7),流动相B为pH7.3磷酸盐缓冲液-乙腈(75:25);线性梯度洗脱;流速为1.0 mL/min;柱温为30℃;检测波长为210 nm;进样体积10μL。结果亚胺培南峰与各杂质峰分离度良好,亚胺培南在0.5~100.0μg/mL范围内线性良好,检测限为0.2μg/mL(0.02%),重复性符合规定。结论本方法灵敏度高,分离效果好,可实现对亚胺培南已知杂质和聚合物杂质进行同时检测。Objective To optimize the determination method of related substances in imipenem.Methods The HPLC analysis was performed on a C18 column(Inertsil ODS-3,4.6 mm×250 mm,5μm);the mobile phase A was phosphate buffer-acetonitrile(99.3:0.7,V/V)with pH value of pH7.3,and the mobile phase B was phosphate bufferacetonitrile(75:25,V/V)with pH value of pH7.3.The gradient elution was performed,and the flow rate was 1.0 mL/min.The column temperature was 30℃,and the detection wavelength was 210 nm.The injection volume was 10μL.Results The peaks of imipenem and its related substances were separated well.The linearity was good within the range of 0.5~100.0μg/mL,and the limit of detection was 0.2μg/mL(0.02%).Repeatability met the requirements.Conclusion The method had the advantages of high sensitivity and good resolution,and could be used for the simultaneous detection of impurities and polymers.

关 键 词：亚胺培南 有关物质 聚合物 方法优化 质量控制 

分 类 号：R978.1[医药卫生—药品]