论文部分内容阅读
目的研究液质联用(LC-MS/MS)法测定人血浆中卡马西平浓度的不确定度。方法本研究对卡马西平浓度测定过程中各影响因素,包括测定精密度、称量、标准溶液的配制、含药血浆的配制、血浆样品预处理、仪器、标准曲线拟合等进行分析评定,采用A类评定程序评价了分析过程中随机效应引起的不确定度,用B类评定程序评价了分析过程的其他因素引起的不确定度,根据各分量计算得到扩展不确定度和合成不确定度。结果人血浆中100,800 ng·mL~(-1)卡马西平的扩展不确定度分别为15.86,52.01 ng·mL~(-1),(P=95%,k=2)。结论 LC-MS/MS法测定人血浆中卡马西平浓度的不确定度主要由标准曲线拟合和回收率引入。
Objective To study the uncertainty of determination of carbamazepine concentration in human plasma by liquid chromatography-mass spectrometry (LC-MS / MS). Methods In this study, the influencing factors of the determination of carbamazepine concentration, including precision, weighing, preparation of standard solution, preparation of drug-containing plasma, pretreatment of plasma samples, instrument, standard curve fitting, A type A rating process was used to evaluate the uncertainty caused by random effects in the analysis process. The type B rating process was used to evaluate the uncertainty caused by other factors in the analysis process. Based on each component, the expanded uncertainty and the combined uncertainty . Results The expanded uncertainty of 100,800 ng · mL -1 carbamazepine in human plasma were 15.86 and 52.01 ng · mL -1, respectively (P = 95%, k = 2). Conclusion The uncertainty of LC-MS / MS method for the determination of carbamazepine concentration in human plasma is mainly induced by standard curve fitting and recovery.