HPLC-MS/MS法测定人血浆头孢克肟浓度的不确定度分析  

Uncertainty of Measurement for Cefixime in Human Plasma by HPLC-MS/MS

作　　者：李力[1] 翟学佳[1] 

机构地区：[1]华中科技大学同济医学院附属协和医院药剂科,武汉430022

出　　处：《医药导报》2015年第9期1150-1154,共5页Herald of Medicine

摘　　要：目的探讨高效液相色谱-质谱联用(HPLC-MS/MS)法测定人血浆头孢克肟浓度的不确定度。方法对HPLC-MS/MS法测定血浆头孢克肟浓度的全过程进行分析,包括测定重复性、称量、标准溶液的配制、血浆样本的处理、仪器、标准曲线拟合等,计算合成不确定度和扩展不确定度。结果置信概率为95%时,血浆低(80 ng·m L-1)、中(560 ng·m L-1)、高(9 600 ng·m L-1)浓度头孢克肟的扩展不确定度分别为14.93,23.65,137.95 ng·m L-1。结论HPLC-MS/MS法测定血浆头孢克肟浓度含量的不确定度主要由标准曲线的拟合、重复性及仪器允差引入。Objective To develop a method on evaluating the uncertainty during the determination of cefixime in human plasma by high performance liquid chromatography-tandem mass spectrometry( HPLC-MS/MS). Methods We analyzed various factors that can cause the uncertainty in the whole process of determination,which includ repeatability,weighting,preparation of standard solutions,sample preparation,equipment error and calibration curve fitting. The expanded uncertainty was evaluated by calculating uncertainty of each component and combined. Results The expanded uncertainty for low( 80 ng · m L-1),medium( 560 ng · m L-1) and high( 9 600 ng · m L-1) level of cefixime was 14. 93,23. 65,137.95 ng·m L-1,respectively( P= 95%). Conclusion The uncertainty of determining cefixime in human plasma by HPLCMS/MS is mainly caused by the calibration curve fitting,repeatability and HPLC-MS/MS error.

关 键 词：头孢克肟 高效液相色谱-质谱联用法 血浆 不确定度 

分 类 号：R978.11[医药卫生—药品] R969.1[医药卫生—药学]