摘要
目的对高效液相色谱串联质谱(HPLC-MS/MS)法测定人血浆中左乙拉西坦浓度的不确定度进行评定。方法用HPLC-MS/MS法测定人血浆中左乙拉西坦浓度,对测试过程进行分析,对各个影响因素,包括测定精密度、标准曲线拟合、称量、标准溶液的配制、含药血浆的配制、提取回收率、基质效应、仪器等进行分析评定,计算合成不确定度和扩展不确定度。结果血浆中低(0.100 2 mg·L-1)、中(2.004 mg·L-1)、高(30.06 mg·L-1)左乙拉西坦浓度测定的合成不确定度为0.010 50、0.123 3、1.958 0 mg·L-1,扩展不确定度分别为0.021 00、0.246 6、3.916 0 mg·L-1。结论 HPLC-MS/MS法测定人血浆中左乙拉西坦浓度的不确定度主要由标准曲线拟合(低浓度)、仪器误差、标准溶液的配制和含药血浆的配制引入。
Objective To evaluate the uncertainty of the determination of Levetiracetam in human plasma by HPLC - MS/MS. Methods The concentration of Levetiracetam in human plasma was determined by HPLC - MS/MS. Various factors including repeatability, calibration curve fitting,weighing, solution preparation, drug - spiked plasma preparation, recovery, and matrix effect were analyzed and evaluated. The combined uncertainty and expanded uncertainty were calculated. Results The combined uncertainty and expanded un- certainty of Levetiracetam were 0.01050 mg·L^-1 and 0. 021 00 mg·L^-1 for low concentration,0. 123 3 mg·L^-1and 0. 246 6 mg·L^-1 for medium concentration,and I. 958 0 mg·L^-1 and 3. 916 mg·L^-1 for high concentration,respectively. Conclusions The uncertainty was mainly caused by the standard curve fitting （low concentration ） , equipment error, solution preparation and sample pre- treatment when determine Levetiracetam in human plasma by HPLC -MS/MS.
出处
《安徽医药》
CAS
2016年第2期253-258,共6页
Anhui Medical and Pharmaceutical Journal
基金
常州四药临床药学会科研基金(No SYSD2015142)
