Validated GC-MS methods to detect ethylene, diethylene, and triethylene glycol in serum, plasma, and urine samples.

IF 1.9 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2025-05-22 DOI:10.1080/17576180.2025.2506352

Nicolas Abrigo, Susan Daniela Selaya, Adil Mohammad, Diaa Shakleya, Dustin G Brown, Jinhui Zhang, Valerie Pratt, Jody E Green, Amanda Degunia, Michael Bennett, Kaitlyn Bloom, Lynnette Rogers, Aiman Q Khan, Robert O Heuckeroth, Patrick J Faustino

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引用次数: 0

Abstract

Background: While Polyethylene glycol 3350 (PEG 3350) is approved by the USFDA for short term use by adults, it is commonly recommended for use in constipated children. Multiple reports of adverse events in children taking PEG 3350 raised safety concerns suggesting that low molecular weight species of PEG 3350 might be absorbed from the gut and cause side effects such as ethylene glycol (EG), diethylene glycol (DEG), and triethylene glycol (TEG).

Research design and methods: This article documents the development, validation, and application of analytical methods using GC-MS and GC-MS/MS for the quantitation of EG, DEG, and TEG in human plasma, serum, and urine.

Results: The analytical range for EG, DEG, and TEG was 2-20 µg/mL. The sample preparation process involves derivatization using N,O-bis(trimethylsilyl) trifluoroacetamide with 1% trimethylchlorosilane in each biological matrices. Deuterated internal standards for each of the analytes were included to provide accurate quantitation of the glycol analytes.

Conclusions: The validated methods were applied to analyze samples a pilot study of children taking PEG 3350. DEG and TEG were detected at levels below the limit of quantitation. In summary, a platform of analytical methods was developed to evaluate glycol analogs in urine, serum, and plasma clinical samples.

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验证气相色谱-质谱法检测血清、血浆和尿液样本中的乙烯、二乙烯和三甘醇。

背景：虽然聚乙二醇3350 （PEG 3350）被美国食品药品监督管理局批准用于成人短期使用，但它通常被推荐用于便秘儿童。多份关于服用PEG 3350的儿童不良事件的报告引发了安全性担忧，表明低分子量的PEG 3350可能被肠道吸收，并导致乙二醇（EG）、二甘醇（DEG）和三甘醇（TEG）等副作用。研究设计和方法：本文记录了GC-MS和GC-MS/MS用于测定人血浆、血清和尿液中EG、DEG和TEG的分析方法的开发、验证和应用。结果：EG、DEG、TEG的分析范围为2 ~ 20µg/mL。样品制备过程包括在每种生物基质中使用N， o -二（三甲基硅基）三氟乙酰胺与1%三甲基氯硅烷进行衍生化。每种分析物的氘化内部标准都包括在内，以提供乙二醇分析物的准确定量。结论：验证的方法适用于对服用PEG 3350的儿童进行初步研究。DEG和TEG均低于定量限。总之，开发了一个分析方法平台来评估尿、血清和血浆临床样本中的乙二醇类似物。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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.