药代动力学实验室液相色谱串联质谱仪期间核查方法的建立  

Establishment of intermediate verification method of liquid chromatography-tandem mass spectrometry in pharmacokinetics laboratory

作　　者：金冠钦[1] 孙黎[1] 王玉洪 夏玲红[1] 林厚文[1] JIN Guanqin;SUN Li;WANG Yuhong;XIA Linghong;LIN Houwen(Department of Pharmacy,Renji Hosptial,School of Medicine,Shanghai Jiao Tong University,Shanghai 200127,China)

机构地区：[1]上海交通大学医学院附属仁济医院药学部,上海200127

出　　处：《化学分析计量》2020年第3期107-112,共6页Chemical Analysis And Meterage

基　　金：上海市科学技术委员会项目(17411964500)。

摘　　要：建立符合ISO17025认可要求的药代动力学实验室中液相色谱串联质谱仪的期间核查方法。采用仪器状态及性能核查、仪器比对及全国室间质评等手段,对液相色谱质谱联用仪检测结果的有效性及准确性进行评价。结果为仪器状态及性能核查指标全部合格;仪器比对采用API 3200QTrap与API 4000的测试数据进行比较,结果两组间精密度(ρ=0.072,P>0.05)及均值(ρ=0.380,P>0.05)均无差异;全国室间质评5组盲样的测试浓度均在允许范围内,全部合格通过。2019年度液相色谱质谱联用仪期间核查结果为满意。期间核查可系统评价液相色谱质谱联用仪的性能,提高检测质量,以满足CNAS CL-01:2018对药代动力学实验室仪器的要求。A method of intermediate verification of liquid chromatography-tandem mass spectrometry in ISO17025-accredited pharmacokinetics laboratory was established.The validity and accuracy of LC-MS/MS were evaluated by the test of instrument performance and states,instrument comparison and external quality assessment(EQA).The test of instrument performance and states was passed.There was no difference in precision(ρ=0.072,P>0.05)and mean value(ρ=0.380,P>0.05)between the group of API 3200QTrap and API 4000.The test of 5 blind samples was passed because the concentrations were also within the allowable range in external quality assessment.So the result of intermediate verification of LC-MS/MS was satisfactory.The performance of LC-MS/MS can be evaluated during the intermediate verification which can also improve the quality of the detection,to meet the instruments requirements of CNAS(China National Accreditation Service for Conformity Assessment)CL-01:2018 in pharmacokinetics laboratory.

关 键 词：ISO 17025 液相色谱串联质谱仪 期间核查 药代动力学实验室 

分 类 号：O657.7[理学—分析化学]