Page 21 - 理化检验-化学分册2024年第十二期

刘子琪，等：液相色谱-高分辨质谱法定性定量检测血液透析器中3种未知可沥滤物

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Qualitative and Quantitative Detection of 3 Unknown Leachable Substances in

Hemodialyzers by Liquid Chromatography-High Resolution Mass Spectrometry

LIU Ziqi , HUANG Yuanli , FU Bufang 1*
1,2
1
(1. National Institutes for Food and Drug Control, Beijing 102629, China; 2. Shandong Lab of Advanced Biomaterials and Medical
Devices in Weihai, Weihai 264209, China)

Abstract: Referring to the hemodialyzer instructions and GB/T 14232. 1—2020, water and ethanol-water mixed solution
were used to extract leachable substances from the hemodialyzer. The chromatography and mass spectrometry information of unknown
leachable substances in the extract was collected by liquid chromatography-high resolution mass spectrometry. The qualitative process
was introduced using dimethylacetamide as an example, and the content of leachable substances was determined by external standard
method. It was shown that 3 leachable substances were found around 1. 7, 2. 1, 2. 5 min, which were determined to be 2-pyrrolidone,
dimethylacetamide, and N-methylpyrrolidone after mass spectrometry analysis and comparison with reference substances. Linear
relationships between values of the mass concentration of 3 leachable substances and the corresponding peak area of quantitative ions
were kept in the ranges of 0. 089 6−4. 48 mg · L −1 , 0. 469 5−18. 78 mg · L −1 , and 0. 102 6−5. 130 mg · L −1 , with detection
−1
limits (3S/N) of 0. 005 1, 0. 009 9, 0. 010 5 μg · g . The method was used for the analysis of 28 hemodialyzers, and the leaching
amounts of 3 leachable substances in ethanol-water extract were higher than those in water extract, with the maximum leaching
amounts of 376. 7, 2 668. 4, 517. 8 μg, respectively.
Keywords: hemodialyzer; liquid chromatography-high resolution mass spectrometry; leachable substance

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