采用高效液相色谱-电喷雾电离质谱检测法对环氧乙烷灭菌医疗器械中残留乙二醇进行灵敏测定。

A sensitive estimation of residual ethylene glycol in ethylene oxide sterilized medical devices by HPLC with electrospray ionization mass spectrometric detection.

作者信息

Hari P R, Naseerali C P, Sreenivasan K

机构信息

Laboratory for Polymer Analysis, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Poojapura, Trivandrum 695012, India.

出版信息

J Chromatogr B Analyt Technol Biomed Life Sci. 2009 Jan 15;877(3):328-32. doi: 10.1016/j.jchromb.2008.12.016. Epub 2008 Dec 11.

DOI:10.1016/j.jchromb.2008.12.016

PMID:19112050

Abstract

A novel analytical methodology for the estimation of residual ethylene glycol (EG) in ethylene oxide sterilized polymer is reported. The method involves the monitoring of ammonium adduct of EG ions in the presence of 10 mM ammonium acetate buffer and methanol using electrospray ionization liquid chromatography and mass spectrometry (LC-ESI-MS). The method enables the detection and quantification of EG without prior derivatization up to a level of 0.06 microg/ml. The potentiality of the method is demonstrated by estimating EG in ethylene oxide (EtO) sterilized polyethylene terephthalate fabric used in heart valve sewing ring. The method is simple, rapid and can routinely be used for the quantification of residual EG in EtO sterilized medical devices.

摘要

报道了一种用于估算环氧乙烷灭菌聚合物中残留乙二醇（EG）的新型分析方法。该方法涉及在10 mM醋酸铵缓冲液和甲醇存在下，使用电喷雾电离液相色谱和质谱（LC-ESI-MS）监测EG离子的铵加合物。该方法无需预先衍生化即可检测和定量EG，检测限可达0.06微克/毫升。通过估算用于心脏瓣膜缝合环的环氧乙烷（EtO）灭菌聚对苯二甲酸乙二酯织物中的EG，证明了该方法的潜力。该方法简单、快速，可常规用于定量EtO灭菌医疗器械中的残留EG。