HPLC梯度洗脱法测定依托咪酯乳状注射液的有关物质  

HPLC determination of related substances in etomidate emulsion injection by gradient elution

作　　者：郑伟军 薛巧如[1] 陈华[1] 邓锋[1] ZHENG Weijun;XUE Qiaoru;CHEN Hua;DENG Feng(Guangdong Institute for Drug Control,Guangzhou 510663,China)

机构地区：[1]广东省药品检验所,广州510663

出　　处：《中国药品标准》2023年第2期138-143,共6页Drug Standards of China

基　　金：广东省药品监督管理局科技创新项目(编号:2022TDZ04)。

摘　　要：目的:建立测定依托咪酯乳状注射液中的有关物质的HPLC方法。方法:色谱柱为Waters SpherisorbC8(4.6 mm×250 mm, 10μm);流动相为磷酸二氢钾溶液-乙腈-80%-四氢呋喃,梯度洗脱;柱温为40℃;检测波长为220 nm,采用外标法与自身对照法。结果:依托咪酯与依托咪酸能较好分离,依托咪酸相邻各峰间分离度均大于1.5;依托咪酸的线性范围为10.0~100.0μg·mL^(-1)(r=0.999 9);平均回收率(n=9)为99.5%。结果表明,B企业产品中依托咪酸的含量相对较高,其他杂质也高于A企业产品。结论:所建方法简便快捷、专属性强、重复性好,可用于依托咪酯乳状注射液中的有关物质检查。Objective:To establish an HPLC method for the determination of etomidate emulsion injection.Methods:The Waters Spherisorb C 8 column(4.6 mm×250 mm,10μm)was adopted with monopotassium phosphate solution-acetonitrile-80%oxolane as the mobile phase by gradient elution.The column temperature was 40℃,and the detection wavelength was set at 220 nm.Results:Etomidate and etomiacid were well separated(r=0.9999)with more than 1.5 of the resolution of etomidate and 10.0-100.0μg·mL^(-1) of linear range of etomiacid.The average recovery was 99.5%.The content of etomiacid in the products of company B was relatively high,and other impurities were also higher than those in the products of company A.Conclusion:The method is simple,rapid,specific and reproducible,and can be used for the determination of related substances in etomidatee mulsion injection.

关 键 词：高效液相色谱法 有关物质 依托咪酯 依托咪酸 

分 类 号：R921.2[医药卫生—药学]