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 16.4 1区 化学 Q1 CHEMISTRY, MULTIDISCIPLINARY
Accounts of Chemical Research 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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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
Accounts of Chemical Research
Accounts of Chemical Research 化学-化学综合
CiteScore
31.40
自引率
1.10%
发文量
312
审稿时长
2 months
期刊介绍: Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.
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