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目的:评定HPLC-MS/MS法测定人血浆中双肼屈嗪浓度的不确定度。方法:对双肼屈嗪浓度测定过程中各影响因素进行分析,包括测定精密度、称量、标准溶液的配制、含药血浆的配制、血浆提取、仪器、标准曲线拟合等进行分析评定,以此计算各变量的不确定度和合成不确定度,最终计算扩展不确定度。结果:人血浆中硫酸双肼屈嗪(40 ng·m L-1)的扩展不确定度为2.342 18 ng·m L-1(P=95.45%,k=2)。结论:HPLC-MS/MS法测定人血浆中双肼屈嗪浓度的不确定度主要由标准曲线拟合和仪器引起。
OBJECTIVE: To assess the uncertainty of HPLC determination of hydralazine concentration in human plasma by HPLC-MS / MS. Methods: The influencing factors in the determination of dihydralazine concentration were analyzed, including the determination of precision, weighing, the preparation of standard solution, the preparation of drug-containing plasma, plasma extraction, equipment, standard curve fitting, In order to calculate the uncertainty of each variable and the synthesis of uncertainty, the final calculation of extended uncertainty. Results: The extended uncertainty of the plasma concentration of dihydralazine sulfate (40 ng · m L -1) in human plasma was 2.342 18 ng · m L-1 (P = 95.45%, k = 2). Conclusion: The uncertainty of HPLC determination of dihydralazine concentration in human plasma by HPLC-MS / MS is mainly caused by the standard curve fitting and the instrument.