| 宗顺麟,张全英,俞蕴莉,等.HPLC-MS/MS法测定人血浆中左乙拉西坦浓度的不确定度分析[J].安徽医药,2016,20(2):253-258. |
| HPLC-MS/MS法测定人血浆中左乙拉西坦浓度的不确定度分析 |
| Uncertainty evaluation of Levetiracetam concentration in human plasma by HPLC-MS/MS |
| 投稿时间：2015-08-20 |
| DOI： |
| 中文关键词: 左乙拉西坦 高效液相色谱串联质谱法 不确定度 |
| 英文关键词: levetiracetam HPLC-MS/MS uncertainty金项目:常州四药临床药学会科研基金(No SYSD2015142) 通信作者:张全英,女,主任药师,硕士生导师,研究方向:临床药学,E-mail:sdfeyyq@163.com |
| 基金项目:常州四药临床药学会科研基金(No SYSD2015142) |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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 uncertainty of Levetiracetam were 0.01050 mg·L-1 and 0.021 00 mg·L-1for low concentration,0.123 3 mg·L-1 and 0.246 6 mg·L-1 for medium concentration,and 1.958 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 pretreatment when determine Levetiracetam in human plasma by HPLC-MS/MS. |
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