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Journal of the Korean Chemical Society (JKCS)

ISSN 1017-2548(Print)
ISSN 2234-8530(Online)
Volume 62, Number 3
JKCSEZ 62(3)
June 20, 2018 

Analysis of Nitrosamines Concentration in Condom by using LC-MS/MS

LC-MS/MS를 이용한 콘돔에 함유된 니트로사민류 농도 분석
Na Youn Park, Sungmin Kim, Woong Jung, Younglim Kho*

박나연, 김성민, 정 웅, 고영림*
니트로사민류, 콘돔, LC-MS/MS , Nitrosamines, Condom, LC-MS/MS
니트로사민류는 이차아민과 아질산이 니트로소화 반응을 통해 생성되는 화합물이며, 고무의 가공시 가황과정을 거치 면서 생성되는 것으로 밝혀졌다. 최근 고무제품 중에서 니트로사민류가 검출되면서 큰 이슈가 되고 있다. 콘돔은 인체에 삽입되 는 일회용 의료기기로써 피부 및 점막에 직접 접촉하므로 안전성이 매우 중요하다. 이에 본 연구에서는 ISO 29941 방법을 준용 하여 콘돔 중 니트로사민류의 분석법을 개발하였다. 콘돔 시료를 증류수에 넣어 용출시키고, 용출액에서 분석대상 물질을 추출 하기 위해 디클로로메탄으로 액체-액체 추출을 실시하였으며, 농축 후 LC-MS/MS에서 정량분석하였다. 분석법의 정확도는 85.8~108.7%, 정밀도는 11.5% 이하, 검출한계는 0.11(NDPA, NDBA) ~ 0.48(NPYR) ng/mL이었다. 31건의 콘돔시료 중에서 증류 수 용출에 의해 검출된 물질은 NDBA 2건이었고, 인공타액(pH 4.5) 용출로 검출된 물질은 NDMA 1건, NDEA 4건, NDBA 26건 이었다. 니트로사민류의 총량은 모든 시료에서 500 μg/kg을 초과하지 않았다.

Nitrosamines are the nitrosocompounds which are produced by nitrosation reactions of the secondary amine and nitrite, and has been found to be produced through the vulcanization process during the production of rubber products Recently, nitrosamines have been detected in rubber products and become a major topic. Condoms are disposable medical devices, so safety is important because they come into direct contact with the skin and mucous membranes. In this study, we developed an analytical method for nitrosamines in condoms by applying ISO 29941 method. The samples were eluted by distilled water, and target compounds were extracted by liquid-liquid extraction with dichloromethane. And then after concentrated, and quantitatively analyzed by LC-MS/MS. The accuracies of the analytical method were ranged from 85.8 to 108.7%, precisions were lower than 11.5%, and the detection limits were from 0.11 (NDPA and NDBA) to 0.48 (NPYR) ng/mL. Among the 31 condom samples, NDBA was detected from 2 cases by extraction of distilled water, and NDMA were detected from 1 case, NDEA from 4 cases and NDBA from 26 cases by extraction of artificial saliva (pH 4.5). The total amount of nitrosamines in all samples were less than 500 μg/kg.

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