摘要
目的对高效液相色谱(HPLC)法测定人血清中拉莫三嗪浓度的不确定度进行评定。方法用HPLC法测定人血清中拉莫三嗪浓度,分析称量、溶液配制、血清提取、标准曲线拟合及测量重复性等因素对结果的影响,计算各因素的不确定度及合成不确定度,并评定扩展不确定度。结果 HPLC法测定人血清中拉莫三嗪低(1.50μg·mL^(-1))、中(8.00μg·mL^(-1))、高(20.00μg·mL^(-1))3个质量浓度质控样品的扩展不确定度分别为UL=0.30,UM=0.53,UH=0.98(P=95%,k=2);其相应检测浓度结果表示为(1.51±0.30),(8.22±0.53),(20.40±0.98)μg·mL^(-1)。结论本方法的相对测定不确定度主要是由重复性、线性拟合及提取回收过程引入,影响低浓度测定结果的因素主要是线性拟合及测量重复性。
Objective To evaluate the uncertainty in the determination of lamotrigine（LTG） in human serum with high performance liquid chromatography（HPLC）.Methods It was analyzed that the influences of various factors for detection results,including weighing,solution preparation,serum extraction,calibration curve fitting repeatability and so on.The expanded uncertainty was evaluated and combined by each component of uncertainty.Results The expanded uncertainty of lamotrigine at low（1.50 μg · mL-1）,middle（8.00 μg · mL-1）,high（20.00μg·mL-1） concentrations were UL= 0.30,UM= 0.53,UH= 0.98,respectively（P = 95%,k = 2）.The corresponding test concentration were（1.51 ± 0.30）,（8.22 ± 0.53）,（20.40 ± 0.98） μg·mL-1,respectively.Conclusion The relative uncertainty on the determination of lamotrigine in human serum by HPLC was mainly caused by repeatability,calibration curve fitting and extraction recovery; repeatability and calibration curve fitting were the important factor in influencing the results of low concentrations.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2017年第22期2295-2298,共4页
The Chinese Journal of Clinical Pharmacology
基金
国家自然科学基金资助项目(81403016)
广东省自然科学基金资助项目(2015A030313808)
广东省医院药学研究(正大天晴基金)基金资助项目(2017A12)
广东省广州市重点学科建设院内基金资助项目(GBH2014-ZD07)
