ICP-TOFMS测定葡萄糖酸钙锌口服溶液中铝元素的迁移

Determination of aluminum migration in calcium and zinc gluconate oral solution by ICP-TOFMS

目的建立电感耦合等离子体发射飞行时间质谱仪(ICP-TOFMS)法测定葡萄糖酸钙锌口服溶液中铝元素的迁移量。方法样品经硝酸和盐酸微波消解后,采用外标法,建立ICP-TOFMS法对葡萄糖酸钙锌口服溶液中的铝元素含量进行测定。同时考察样品经低温冻融、影响因素、加速和长期试验留样过程中包材中铝元素的迁移。结果铝元素在0~100 ng·mL^(-1)内线性关系良好(r=0.9982),检测限和定量限分别为0.92 ng·mL^(-1)、3.05 ng·mL^(-1),低、中、高浓度加样回收率分别为91.55%、83.67%、84.67%,RSD分别为9.1%、4.1%、4.4%。结论在低温冻融试验中,铝元素含量均未检出;在影响因素试验、加速试验和长期试验中,铝元素含量有增长趋势,但远低于限度(8.3μg·mL^(-1)),故所选包材铝元素迁移风险较小。

Objective To establish an ICP-TOFMS method to determine aluminum migration from packaging materials in calcium and zinc gluconate oral solution.Methods After microwave digestion with nitric acid and hydrochloric acid,ICP-TOFMS method was established to determine the content of aluminum in calcium and zinc gluconate oral solution by external standard method.At the same time,cryogenic freezing-thawing,influence factors,acceleration and long-term tests were conducted to determine the amount of aluminum migration.Results The linearity of aluminum was good in the concentration range of 0~100 ng·mL^(-1)(r=0.9982).The limit of detection and quantitation were 0.92 ng·mL^(-1) and 3.05 ng·mL^(-1),respectively.The low,medium,and high concentration recovery was 91.55%,83.67%,and 84.67%,with RSD of 9.1%,4.1%,and 4.4%.In the cryogenic freezing-thawing test,the content of aluminum was not detected.Conclusion With influence factors,accelerations and long-term tests,the aluminum content tends to increase but is far below the limit(8.3μg·mL^(-1)).So risk of aluminum migration from the selected packaging material is small.