用于血浆拉莫三嗪分析的超高效液相色谱-质谱/质谱法以及与同源酶免疫分析法的比较。

IF 1.9 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2024-02-01 Epub Date: 2024-02-09 DOI:10.4155/bio-2023-0183

Xiaoxu Shi, Dongjie Zhang, Zhigang Zhao, Shenghui Mei

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引用次数: 0

摘要

目的：开发并验证一种超高效液相色谱-质谱/质谱法，用于分析人血浆中的拉莫三嗪（LTG），并评估其与均相酶免疫分析法（HEIA）的一致性。材料与方法：根据 USFDA/EMA 指南开发并验证了超高效液相色谱-质谱/质谱方法。采用 Bland-Altman 图评估 UHPLC-MS/MS 与 HEIA 的一致性。结果：样品经一步蛋白质沉淀预处理后，在 2.6 分钟内完成分离。日内和日间偏差和不精确度分别为-15.8%至15.0%和小于11.17%。回收率和基质因子为 98.30% 至 111.97%。与 HEIA 相比，UHPLC-MS/MS 的平均高估率为 21.57%。结论建立并验证了一种快速、灵敏、稳健的超高效液相色谱-质谱/多反应监测（UHPLC-MS/MS）分析血浆中LTG的方法。

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UHPLC-MS/MS for plasma lamotrigine analysis and comparison with a homogenous enzyme immunoassay.

Aims: To develop and validate a UHPLC-MS/MS method for lamotrigine (LTG) analysis in human plasma and evaluate its agreement with a homogenous enzyme immunoassay (HEIA). Materials & methods: The UHPLC-MS/MS method was developed and validated according to the USFDA/EMA guidelines. A Bland-Altman plot was used to evaluate the agreement between UHPLC-MS/MS and HEIA. Results: Samples were pretreated with one-step protein precipitation and separated in 2.6 min. The intra- and inter-day bias and imprecisions were -15.8 to 15.0% and less than 11.17%, respectively. The recovery and matrix factor were 98.30 to 111.97%. The mean overestimation of UHPLC-MS/MS compared with HEIA was 21.57%. Conclusion: A rapid, sensitive and robust UHPLC-MS/MS method for plasma LTG analysis was developed and validated and was a 21.57% overestimation compared with HEIA.

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来源期刊

Bioanalysis BIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL

CiteScore

3.30

自引率

16.70%

发文量

审稿时长

2 months

期刊介绍： Reliable data obtained from selective, sensitive and reproducible analysis of xenobiotics and biotics in biological samples is a fundamental and crucial part of every successful drug development program. The same principles can also apply to many other areas of research such as forensic science, toxicology and sports doping testing. The bioanalytical field incorporates sophisticated techniques linking sample preparation and advanced separations with MS and NMR detection systems, automation and robotics. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality. Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing. The journal Bioanalysis focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques. Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.