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目的评定HPLC-MS/MS测定大鼠脑微透析液中斑蝥酸(CTR)浓度的不确定度。方法用HPLC-MS/MS法测定大鼠脑微透析液中CTR浓度,分析并评定过程中的不确定度来源,并进行合成。结果大鼠脑微透析液中CTR低、高浓度(0.19,35.90 ng·m L~(-1))的扩展不确定度分别为0.02,2.08ng·m L~(-1)(P=95%,k=2)。结论本方法的不确定度在低浓度时主要由基质效应、曲线拟合、重复性和生物药品配制引入,在高浓度时主要由基质效应、重复性和生物药品配制引入。
Objective To assess the uncertainty of the concentration of cantharidin (CTR) in rat brain microdialysate by HPLC-MS / MS. Methods The concentration of CTR in rat brain microdialysate was determined by HPLC-MS / MS. The source of uncertainty in the process of analysis and evaluation was analyzed and synthesized. Results The expanded uncertainty of CTR and high concentration (0.19, 35.90 ng · m L -1) of rat brain microdialysis solution were 0.02, 2.08ng · m L -1 (P = 95 %, k = 2). Conclusions The uncertainty of this method is mainly introduced by matrix effect, curve fitting, repeatability and biopharmaceutical formulation at low concentration. It is mainly introduced by matrix effect, repeatability and biopharmaceutical formulation at high concentration.