摘要
建立电感耦合等离子体质谱(ICP-MS)法同时测定卤化丁基胶塞在5种浸提溶液中的10种元素含量。卤化丁基胶塞分别在5种浸提溶剂(pH 3.5醋酸盐缓冲液、水、pH 7.0磷酸盐缓冲液、3%柠檬酸溶液、20 mmol甘氨酸溶液)中提取后,用ICP-MS检测铬(Cr)、钴(Co)、镍(Ni)、铜(Cu)、砷(As)、锡(Sn)、锑(Sb)、钡(Ba)、铅(Pb)、镉(Cd)共10种元素的含量,并进行方法学验证。结果表明,5种提取溶液中,各元素在0.1~60.0 ng/mL范围内线性关系良好(r=0.979 8~1.000 0),检出限在0.005~1.382 ng/mL之间,定量限在0.016~4.606 ng/mL之间,加标回收率为90.0%~118.7%。该方法简单、灵敏、准确、快速,可用于卤化丁基胶塞产品元素不同提取溶液的迁移测定,为药品包装材料的质量监督提供参考依据。
To establish an inductively coupled plasma mass spectrometry(ICP-MS) method for determination of 10 metal elements in halogenated butyl rubber stopper of five extraction solutions.Methods: ICP-MS was used to detect the assay of Cr, Co, Ni, Cu, As, Sn, Sb, Ba, Pb, Cd in the extraction solutions of halogenated butyl rubber stopper in pH 3.5 acetate buffer solution, water, pH 7.0 phosphate buffer solution, 3% citric acid solution, 20mmol glycine solution, respectively. The new method accords with method validation.Results: The linear range of each element was 0.1~60.0 ng/mL in five extraction solutions was good(r=0.979 8~1.000 0), the detection limit was between 0.005~1.382 ng/mL, and the quantitation limit was between 0.016~4.606 ng/mL, the sample recovery rate of all elements was between 90.0%~118.7%. Conclusion: The method is specific, sensitive, accurate and rapid, which can be used for the determination of elements in halogenated butyl rubber of five different extraction solutions and provide reference for drug packaging materials quality supervision.
作者
刘若锦
甄晓兰
王子梦
邢娣娣
李挥
Liu Ruojin;Zhen Xiaolan;Wang Zimeng;Xing Didi;Li Hui(Hebei Institute for Drug and Medical Devices Control,Shijiazhuang 050227,China)
出处
《塑料助剂》
CAS
2022年第3期1-6,11,共7页
Plastics Additives
基金
河北省“三三三人才工程”资助项目:新型冠状病毒(COVID-19)检测方法的评价研究(A202001059)。
