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作 者:虞雪军 杨婷婷 吴珍 占翌领 易路遥 YU Xuejun;YANG Tingting;WU Zhen;ZAN Yiling;YI Luyao(Jiangxi Institute For Drug Control,NMPA Key Laboratory of Quality Evaluation of Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China)
机构地区:[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029
出 处:《药品评价》2021年第24期1493-1496,共4页Drug Evaluation
基 金:江西省重点研发计划项目(20203BBGL73212);江西省药品监督管理局科技计划(2021KY08)。
摘 要:目的:通过液相色谱-质谱/质谱(LC-MS/MS)技术建立婴幼儿护肤品中28种抗过敏药物的分析方法。方法:样品采取甲醇提取,28种组分经ACQUITY UPLC BEH C18色谱柱分离,质谱正离子模式扫描测定。结果:28种组分在1~15μg/L浓度范围内线性关系良好,相关系数r均大于0.99,方法平均回收率在75.2%~125.3%,相对标准偏差在1.0%~10.0%。结论:该方法快速、简便、准确,适用于婴幼儿护肤品中28种抗过敏药物非法添加的快速筛查。Objective:The analysis method of 28 anti-allergy drugs in infant skin care products was established by liquid Chromatography-tandem mass spectrometry(LC-MS/MS)technology.Methods:Samples were extracted by methanol,28 components were separated by a ACQUITY UPLC BEH C18 chromatography column and determined by mass spectrometry with positive ion scanning mode.Results:The 28 fractions were well linearly in the concentration range of 1 to 15μg/L,with a correlation coefficient r greater than 0.99.The average recovery rate was between 75.2%and 125.3%.Relative standard deviation was between 1.0%and 10.0%.Conclusion:The method was fast,simple and accurate,and suitable for the rapid screening of 28 anti-allergy drugs in infant skin care products.
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