高效液相色谱法测定化妆品中8种维甲酸类药物的不确定度评定  

Evaluation of uncertainty in the determination of 8 retinoic acids in cosmetics by high performance liquid chromatography

作　　者：张小媚 刘小娟[1] ZHANG Xiaomei;LIU Xiaojuan(Guangdong Institute for Drug Control,National Medical Products Administration Key Laboratory for Safety Risk Assessment of Cosmetics,Guangzhou 510663,China)

机构地区：[1]广东省药品检验所,国家药品监督管理局化妆品风险评估重点实验室,广州510663

出　　处：《化学分析计量》2023年第5期93-97,共5页Chemical Analysis And Meterage

摘　　要：建立了数学模型,考察《化妆品安全技术规范》(2015年版)中高效液相色谱法测定化妆品中8种维甲酸类药物含量的不确定度来源,对各组分的含量测定结果进行不确定度评定。结果显示,在95%的置信水平下,包含因子k=2,化妆品中他卡西醇、他扎罗汀、阿维A、异维甲酸、维甲酸、维胺酯、依曲替酯、阿达帕林质量分数分别为0.0077%、0.0448%、0.0418%、0.0409%、0.0473%、0.0377%、0.0406%和0.0159%时,其相对扩展不确定度分别为0.00024%、0.00128%、0.00128%、0.00119%、0.00139%、0.00121%、0.00126%和0.00055%。测量不确定度主要来源于标准溶液的配制、标准曲线拟合、天平称量以及测量重复性,因此分析过程中应注意使用校正级别高的玻璃量器,增加系列标准溶液的校准点数及平行测量次数,以保证测量结果的准确度。The mathematical model for the determination of 8 kinds of retinoids in cosmetics by high performance liquid chromatography(HPLC)was established,according to Safety and Technical Standards for Cosmetics(2015),the measurement uncertainty of each component was evaluated.The results showed that the the extended uncertainties of taccathinol,tazarotene,etretin,isotretinoin,tretinoin,viaminate,etretinate and adapalene were 0.00024%,0.00128%,0.00128%,0.00119%,0.00139%,0.00121%,0.00126%and 0.00055%(95%confidence level,k=2)when their concents in cosmetics were 0.0077%,0.0448%,0.0418%,0.0409%,0.0473%,0.0377%,0.0406%and 0.0159%.The main sources of measurement uncertainty were the preparation of the standard solution,standard curve fitting,balance weighing and measurement repeatability.Therefore,during the analysis process,it should be paid attention to the use of glass measuring device with high correction level,increasing the calibration points and parallel measurement times of series standard solutions to ensure the accuracy of the measurement results.

关 键 词：高效液相色谱法 维甲酸类药物 不确定度 化妆品 

分 类 号：O657.7[理学—分析化学]