- P-ISSN 1225-0163
- E-ISSN 2288-8985
본 연구는 물휴지 중 메탄올 정량법을 확립 및 밸리데이션을 수행하고, 확립된 시험법을 인체세정용 물휴지에 적용하여 검증하는 것을 목적으로 하였다. 물휴지 중 메탄올 정량시험은 헤드스페이스/가스크로마토그래피/불꽃이온화검출기법(HS/GC/FID)을 사용하였고, ‘의약품 등 시험방법 밸리데이션에 대한 가이드라인’에 따라 밸리데이션을 수행하였다. 확립된 시험법에서 메탄올의 정량범위는 3~40 μg/mL 로 나타났으며, 상관계수(R2) 0.999 이상의 직선성과 우수한 선택성을 나타내었고, 검출한계와 정량한계는 각각 0.36와 1.17 μg/mL로 나타났다. 검출범위 내 농도별 회수율을 시험한 결과는 100.67~110.17%를나타났다. 정밀성시험 결과 메탄올 검출량의 상대표준편차(RSD %)는 1.83%로 2 % 이내의 결과를 나타났다. 물휴지 중 메탄올 시험법을 유통 중인 물휴지 20개 제품에 적용하여 검출량을 분석한 결과 20개제품에서 0.00017 %~ 0.00156%로 나타나 검출허용한도 기준 내 적합한 것을 확인하였다.
This research aims to set up and validate methods of analyzing the methanol in wet wipes and verifies the analysis methods that applied to the wet wipes. We used Headspace (HS) Gas Chromatography (GC) - Flame Ionization Detector (FID) to the establish analysis method of methanol in wet wipes and optimized heating temperature, heating time, GC conditions with column. The result indicated that 3 mL of sample in 20 mL headspace vial can be equilibrated efficiently in headspace sampler at 70 oC for 10 min and sample was measured by GC with spli injection mode(10:1). The results show that linearity from 1 to 100 ppm was over R2 0.9995, precision was RSD 1.83 % and accuracy(recovery rate) was 105.44 (±1.05 %) on water matrix and wet wipes matrix removed non-woven fabric. Also, monitoring results of total 20 cosmetics on the market, from 0.00017 to 0.00156 % of methanol was detected from wet wipes.
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