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KMID : 1142220180130010055
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Regulatory Research on Food, Drug & Cosmetic
2018 Volume.13 No. 1 p.55 ~ p.60
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A Study on the Determination of the Piroctone olamine Analysis Method Among Cosmetics using Liquid Chromatography
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Choi Yong-Kyu
Ha Seo-Jun
Choi Yun-Gyeom
Min Chung-Sik
Kim Hyo-Jin
Lee Rhee-Da
Kim Sang-Seop
Han Kyoung-Moon
Son Kyung-Hun
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Abstract
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Piroctone olamine is the ethanolamine salt of hydroxamic acid, which is used as a preservative in cosmetics. In many countries including South Korea and Europe, it is regulated by 1.0% in rinse-off products and 0.5% in other products. In this study, we introduced new analysis methods, determining the amount of piroctone olamine in various cosmetics. These methods were well-validated, followed by “Korean pharmaceutical method validation guideline”. The quantitative method was established by HPLC. The coefficients of determination (r2) were all greater than 0.999 with the standard curve range between 5 and 50 μg/mL for HPLC. They showed an outstanding selectivity to the cosmetic matrices. For HPLC method, the LOD and LOQ were calculated as 0.620 and 1.880 μg/ mL respectively. In the accuracy and precision test for toner, shampoo and lotion matrices, the average recovery rate was 90.7~92.8% and the relative standard deviation (RSD) was 0.5~2.66%. We expect that the results of this study can be usefully applied in QC of prionctone oalmine and contributes to improve the consumer safety. To examine the stability of solution, each sample was stored at room temperature or in refrigerator after pre-treatment, which resulted in being stable. Also, 13 marketed cosmetic products were monitored by developed assay, which contained piroctone olamine. It was found that the content of piroctone olamine was below the regulation limit, which was 1.0% in all tested products. We expect that the results of this study can be usefully applied in QC of piroctone olamine and contributes to improve the consumer safety.
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KEYWORD
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piroctone olamin, Cosmetics, HPLC
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