LC-MS/MS法测定人血浆中利奈唑胺浓度的不确定度评定  

Uncertainty in the determination of linezolid in human plasma by LC-MS/MS

作　　者：刘艳芳 张琛琛 蔡朝红 党大胜 LIU Yan-fang;ZHANG Chen-chen;CAI Chao-hong;DANG Da-sheng(Clinical Trial Center,General Hospital of Northern Theater Command,Shenyang 110840;School of Life Sciences and Biopharmaceutics,Shenyang Pharmaceutical University,Shenyang 110840;Department of Clinical Pharmacy,General Hospital of Northern Theater Command,Shenyang 110840)

机构地区：[1]北部战区总医院临床试验研究室,沈阳110840 [2]沈阳药科大学生命科学与生物制药学院,沈阳110840 [3]北部战区总医院临床药学室,沈阳110840

出　　处：《中南药学》2021年第11期2311-2315,共5页Central South Pharmacy

摘　　要：目的评价本研究室新建立的人血浆中利奈唑胺浓度测定方法的不确定度。方法按照试验流程建立数学模型,用数学模型对影响因素进行量化、合成及扩展。结果置信概率P为95%时,利奈唑胺低、中、高质量浓度可分别表示为(0.395±0.055)μg·mL^(-1)、(4.18±0.351)μg·mL^(-1)和(32.5±3.20)μg·mL^(-1)。结论新方法不确定度主要来自提取回收、线性拟合、样品制备以及基质效应,可以通过增加人员培训,提高操作平行性;线性范围确定的情况下,需要考察标准曲线浓度点数找出最小不确定度值;简化样品制备过程;采用稳定同位素内标或改用其他离子源等方式来降低各项不确定度值。Objective To determine the uncertainty of a new method in the determination of linezolid in human plasma.Methods The mathematical model was established according to the experimental process,and the influence factors in the whole process of determination were quantified,synthesized and expanded by the mathematical model.Results When the confidence probability was 95%,the low,medium and high concentrations of linezolid in human plasma were expressed as(0.395±0.055)μg·mL^(-1),(4.18±0.351)μg·mL^(-1) and(32.5±3.20)μg·mL^(-1).Conclusion The uncertainty of the new method mainly comes from extraction recovery,matrix effect and linear fitting process,which may be reduced by increasing personnel training and improving operational parallelism.With stable isotope internal standard or other ion sources for detection,we may identify the minimum uncertainty by examinating the standard samples.

关 键 词：利奈唑胺 LC-MS/MS 不确定度 

分 类 号：R965[医药卫生—药理学]