他克莫司软膏有关物质测定的影响因素分析  

Analysis of influencing factors on determination of related substances in tacrolimus ointment

作　　者：张兴哲 赵丽元 王冬 韩东 ZHANG Xingzhe;ZHAO Liyuan;WANG Dong;HAN Dong(Dalian Inspection and Certification Technology Service Center,Dalian 116021,China)

机构地区：[1]大连市检验检测认证技术服务中心,大连116021

出　　处：《中国药品标准》2020年第5期435-439,共5页Drug Standards of China

摘　　要：目的:考察测定他克莫司软膏有关物质的影响因素。方法:色谱柱为二醇基柱(Diol)4.6 mm×250 mm,5μm两根串联;以正己烷-正丁基氯-乙腈(7∶2∶1)为流动相;柱温为28℃;流速为1.7 mL·min-1;检测波长为225 nm;进样体积为20μL。选用3种塑料离心管和3种乙酸乙酯分别进行试验。结果:3种塑料离心管均会产生杂质;乙酸乙酯对测定结果会产生影响。结论:测定他克莫司软膏有关物质时应避免塑料和乙酸乙酯对试验结果的影响。Objective:To investigate the influencing factors on determination of related substances of tacrolimus ointment.Method:The test was performed in two tandem Diol columns(4.6 mm×250 mm,5μm)under isocratic elution of n-hexane-n-butyl chloride-acetonitrile(7∶2∶1).The column temperature was 28℃and the flow rate was 1.7 mL·min-1.The detection wavelength was 225 nm,and the injection volume was 20μL.Three kinds of plastic centrifuge tubes and ethyl acetates from 3 different manufacturers were used to test respectively.Results:Three kinds of plastic centrifuge tubes would produce the impurities,and ethyl acetate had the influence on the determination results.Conclusion:The influence of plastic and ethyl acetate on the test results should be avoided for determination of the related substances of tacrolimus ointment.

关 键 词：他克莫司 软膏 有关物质 影响 

分 类 号：R921.2[医药卫生—药学]