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KMID : 1142220180130010045
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Regulatory Research on Food, Drug & Cosmetic
2018 Volume.13 No. 1 p.45 ~ p.54
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Development of Analysis Methods of Cetylpyridinium Chloride in Cosmetic Products by HPLC and LC-ESI-MS/MS
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Park Soon-Young
Ha Seo-Jun
Lee Su-MIn
Lee Sang-Il
Min Chung-Sik
Choi Yong-Kyu
Lee Rhee-Da
Kim Sang-Seop
Seo Kyung-Won
Kim Young-Lim
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Abstract
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In the case of cosmetics, which are frequently used in everyday life, a preservative agent should be contained for the sterilization. Among them, cetylpyridinium chloride (CPC) is widely applied in wet wipes. CPC is regulated by 0.08% in all cosmetic products. In this study, we introduced new analysis methods, determining the amount of CPC in various cosmetics. These methods were well-validated, followed by “Korean pharmaceutical method validation guideline”. The quantitative method was established by HPLC, whereas the identification method was set up by LC-ESI-MS/MS. The coefficients of determination (r2) were all greater than 0.999 with the standard curve range between 1 and 20.0 μg/mL for HPLC, and between 0.05 and 2.0 μg/mL for LC-MS/ MS. They showed an outstanding selectivity to the cosmetic matrices. For HPLC method, the LOD and LOQ were calculated as 0.13 and 0.44 μg/mL respectively. In the accuracy and precision test for toner, lotion, cream and shampoo matrices, the average recovery rate was 100.8% and the relative standard deviation (RSD) was 1.2%. On the other hand, with the LC-MS/MS method, the LOD and LOQ were 0.04 and 0.11 μg/mL each. Also they have the accuracy of 107.66% and the precision of 1.68%. We expect that the results of this study can be usefully applied in QC of CPC and contributes to improve the consumer safety.
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KEYWORD
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Cetylpyridinium chloride, Cosmetics, HPLC, LC-ESI-MS/MS
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