LC-MS法测定人血浆中的头孢克肟及评价两种头孢克肟片的生物等效性  

Determination of Cefixime in human plasma by LC-MS and study on the bioavailability of two Cefixime tablets

作　　者：南峰 陈朝霞 唐诗韵[1] 丁红[1] 阎博华[1] 曾洁萍[1] NAN Feng;CHEN Zhaoxia;TANG Shiyun;DING Hong;YAN Bohua;ZENG Jieping(GCP Center,Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu,Sichuan,610072 P.R.China)

机构地区：[1]成都中医药大学附属医院GCP中心,四川成都610072

出　　处：《华西药学杂志》2020年第5期523-526,共4页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用LC-MS法测定人血浆中头孢克肟的浓度,并用于两种头孢克肟片的一致性评价。方法采用Waters BEH C18色谱柱(50 mm×2.1 mm,1.7μm),梯度洗脱,以MRM模式测定头孢克肟(m/z 454.00→285.15)的浓度,13C3,15N2-头孢克肟作内标(m/z 459.00→290.15),ESI离子源。血浆样本中加入内标,经甲醇沉淀蛋白后,取上清液进样检测。并对两种头孢克肟片进行一致性评价。结果所用方法简便、峰形好,各项方法学考察指标均符合国家药品监督管理局(NMPA)的指导原则及最新核查标准要求。两种制剂生物等效。结论所用方法快速、灵敏,适用于人血浆中头孢克肟浓度的检测及相关试剂的生物学评价。OBJECTIVE To establish an LC-MS method for the determination of Cefixime in human plasma,and to study the bioequivalence of two Cefixime tablets.METHODS The samples were eluted on Waters ACQUITY BEH C18 column(50 mm×2.1 mm,1.7μm)according to gradient elution program Cefixime(m/z 454.00→285.15)and 13C3,15 N2-Cefixime(internal standard,m/z 459.00→290.15)were monitored by ESI in MRM model.The plasma samples were mixed with internal standard,then precipitated protein by methanol,then the supernatants were detected.The bioequivalence between two Cefixime tablets were studied.RESULTS The method was simple,and had better chromatographic peaks.The indexes of methodology investigation all met the guiding principles and criteria of NMPA.The test tablet was bioequivalent to the reference tablet.CONCLUSION This method is rapid and sensitive,and it is suitable for the determination of Cefixime in human plasma and bioequivalence between two Cefixime tablets.

关 键 词：头孢克肟 人血浆 血浆浓度 液质联用 药代动力学 生物等效性 一致性评价 

分 类 号：R917[医药卫生—药物分析学]