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Simultaneous determination of di(2-ethylhexyl) phthalate and diisononylcyclohexane-1,2-dicarboxylate and their monoester metabolites in four labile blood products by liquid chromatography tandem mass spectrometry.
Journal of Pharmaceutical and Biomedical Analysis ( IF 3.1 ) Pub Date : 2019-12-23 , DOI: 10.1016/j.jpba.2019.113063
Amandine Descat 1 , Marie Lecoeur 2 , Mostafa Kouach 1 , Laurence Goossens 2 , Aurélie Thelliez 2 , Pascal Odou 3 , Bertrand Decaudin 3 , Jean-François Goossens 1
Affiliation  

Di(2-ethylhexyl) phthalate (DEHP) is a common plasticizer that is largely used for PVC blood bags. The migration of DEHP from medical devices into labile blood products (LBP) is a well-known situation. While DEHP has beneficial effects on the storage of red blood cells, it can have toxicological impact due to its potential reprotoxic effects (classified group 1B). Since July 1st, 2015, the French law prohibits the use of tubing made in DEHP-plasticized PVC in paediatric, neonatal and maternity wards. This provision, which could extend in several years more widely to medical devices used for drugs infusion, dialysis, feeding and blood bags, has led manufacturers to replace DEHP to alternative plasticizers such as diisononylcyclohexane-1,2-dicarboxylate (DINCH). In this paper, a liquid chromatography-tandem mass spectrometry (LCMS/MS) method has been developed and validated for the determination of DEHP, DINCH and their corresponding monoester metabolites (MEHP and MINCH) in four labile blood products (LBP): whole blood (WB), red cells concentrate (RCC), plasma and platelet concentrate (PC). Due to strong contamination of blank LBP by DEHP because of its ubiquitous presence in working environment and despite the attention paid to avoid contamination of solvents and glassware, a trap chromatographic column was implemented between the solvent mixing chamber and the injector of the LC system. This set-up permitted to discriminate DEHP present in the sample to DEHP brought by the environmental contamination. In the optimized conditions, all compounds were separated in less than 10 min. The analytes were extracted from LBP samples using a liquid-liquid extraction. After optimization, recoveries were ranged from 47 to 96 %, depending on the analytes and the nature of LBP. Except for DEHP which exhibited RSD values of intermediate precision higher than 20 % at a concentration of 25 nM, all the precision results (repeatability and intermediate precision) were lower than 16 % and trueness values ranged from -16.2-19.8%. Using the validated method, the leachability of DEHP and DINCH from corresponding PVC-blood bags was investigated and the concentrations of their corresponding metabolites, MEHP and MINCH, were determined in whole blood, red cells concentrate, plasma and platelet concentrate.

中文翻译:

液相色谱串联质谱法同时测定四种不稳定血液制品中邻苯二甲酸二(2-乙基己基)酯和邻苯二甲酸二异壬基环己烷-1,2-二羧酸酯及其单酯代谢物

邻苯二甲酸二(2-乙基己基)酯(DEHP)是一种常见的增塑剂,主要用于PVC血袋。DEHP从医疗设备到不稳定血液制品(LBP)的迁移是一种众所周知的情况。尽管DEHP对红细胞的储存具有有益作用,但由于其潜在的再毒性作用,它可能具有毒理学影响(分类为1B组)。自2015年7月1日起,法国法律禁止在儿科,新生儿和产科病房中使用DEHP增塑PVC制造的管材。这项规定可以在数年内更广泛地扩展到用于药物输注,透析,喂养和血袋的医疗设备,已导致制造商将DEHP替换为替代增塑剂,例如二异壬基环己烷-1,2-二羧酸酯(DINCH)。在本文中,已开发了液相色谱-串联质谱(LCMS / MS)方法,并已验证该方法可用于测定四种不稳定血液产品(LBP)中的DEHP,DINCH及其相应的单酯代谢物(MEHP和MINCH):全血(WB),红细胞浓缩液(RCC),血浆和血小板浓缩液(PC)。由于DEHP对空白LBP的强烈污染(由于其在工作环境中普遍存在),并且尽管注意避免溶剂和玻璃器皿的污染,但在溶剂混合室和LC系统的进样器之间采用了捕集色谱柱。这种设置可以将样品中存在的DEHP与环境污染带来的DEHP区别开来。在优化的条件下,所有化合物在不到10分钟的时间内即可分离出来。使用液-液萃取从LBP样品中萃取分析物。优化后,根据分析物和LBP的性质,回收率在47%到96%之间。除了DEHP在25 nM的浓度下其RSD值的中间精度高于20%之外,其他所有精度结果(重复性和中间精度)均低于16%,真实值在-16.2-19.8%范围内。使用经过验证的方法,研究了DEHP和DINCH从相应的PVC血袋中的浸出性,并测定了全血,红细胞浓缩液,血浆和血小板浓缩液中其相应代谢产物MEHP和MINCH的浓度。取决于分析物和LBP的性质。除了DEHP在25 nM的浓度下其RSD值的中间精度高于20%之外,其他所有精度结果(重复性和中间精度)均低于16%,真实值在-16.2-19.8%范围内。使用经过验证的方法,研究了DEHP和DINCH从相应的PVC血袋中的浸出性,并测定了全血,红细胞浓缩液,血浆和血小板浓缩液中其相应代谢产物MEHP和MINCH的浓度。取决于分析物和LBP的性质。除了DEHP在25 nM的浓度下其RSD值的中间精度高于20%之外,其他所有精度结果(重复性和中间精度)均低于16%,真实值在-16.2-19.8%范围内。使用经过验证的方法,研究了DEHP和DINCH从相应的PVC血袋中的浸出性,并测定了全血,红细胞浓缩液,血浆和血小板浓缩液中其相应代谢产物MEHP和MINCH的浓度。
更新日期:2019-12-23
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