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目的:评定高效液相色谱-质谱联用法(HPLC-MS/MS)测定人血浆中替加环素(TGC)浓度的不确定度。方法:分析HPLC-MS/MS法测定人血浆中TGC浓度的整个过程,分别评定测量重复性、称量、工作液配制、生物样品配制、回收率、仪器允差和标准曲线拟和引起的不确定度大小,最后计算合成不确定度并进行扩展。结果:人血浆中替加环素低、中、高浓度的测定值和不确定度可分别表示为:(48.737±4.587),(396.067±19.096)和(1 489.000±103.563)ng·ml-1,(P=95%,k=2)。结论:HPLC-MS/MS法测定人血浆中TGC浓度的不确定度主要来源在低浓度时曲线拟合和高浓度时回收率。
OBJECTIVE: To assess the uncertainty of determination of tigecycline (TGC) in human plasma by HPLC-MS / MS. Methods: The whole process of determination of TGC concentration in human plasma was analyzed by HPLC-MS / MS. The repeatability, weighing, preparation of working solution, preparation of biological samples, recoveries, instrument tolerance and standard curve fitting were evaluated respectively Determine the degree of size, the final calculation of the synthesis of uncertainty and expansion. Results: The values and uncertainties of low, medium and high concentrations of tigecycline in human plasma were respectively (48.737 ± 4.587), (396.067 ± 19.096) and (1.489.000 ± 103.563) ng · ml -1 , (P = 95%, k = 2). Conclusion: The main sources of uncertainty in the determination of TGC concentration in human plasma by HPLC-MS / MS are curve fitting at low concentration and recovery at high concentration.