Qualitative and Quantitative Detection of 3 Unknown Leachable Substances in Hemodialyzers by Liquid Chromatography-High Resolution Mass Spectrometry
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 limits(3S/N)of 0.005 1,0.009 9,0.010 5 μg·g-1.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.
hemodialyzerliquid chromatography-high resolution mass spectrometryleachable substance
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