高效液相色谱法测定人血清中拉莫三嗪浓度的不确定度评定

发布时间：2019-03-01 20:03

【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。
[Abstract]:Objective to evaluate the uncertainty of determination of lamotriazine in human serum by high performance liquid chromatography (HPLC). Methods the HPLC method was used to determine the concentration of lamotriazine in human serum. The effects of weighing, solution preparation, serum extraction, standard curve fitting and repeatability on the results were analyzed, and the uncertainty of each factor and the synthetic uncertainty were calculated. The extended uncertainty is evaluated. Results the extended uncertainty for the determination of lamotriazine in human serum (1.50 渭 g 路mL ~ (- 1), (8.00 渭 g 路mL ~ (- 1),) (20.00 渭 g 路mL ~ (- 1) by HPLC was UL=0.30,. UM=0.53,UH=0.98 (P = 95%, k ~ (2); The corresponding detection concentration was (1.51 卤0.30), (8.22 卤0.53), (20.40 卤0.98) 渭 g 路mL ~ (- 1). Conclusion the relative determination uncertainty of this method is mainly introduced by repeatability, linear fitting and extraction and recovery process. The main factors affecting the results of low concentration determination are linear fitting and measurement repeatability.
【作者单位】：广州医科大学附属脑科医院广州市惠爱医院药剂科;广州市民政局精神病院药剂科;
【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)
【分类号】：R969

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