ICP-MS法测定辅酶Q₁₀原料及制剂中22种元素杂质

目的：建立测定辅酶Q₁₀原料及制剂中22种元素杂质的方法。方法：以密闭高压微波消解技术处理样品，采用电感耦合等离子体质谱法以全定量的方式测定镉（Cd）、铅（Pb）、砷（As）、汞（Hg）、钴（Co）、钒（V）、镍（Ni）的含量，以半定量的方式测定其余15种元素杂质的含量。结果：辅酶Q₁₀中Cd、Pb、As、Hg、Co、V、Ni的加样回收率为89.8%~10³.5%，检测下限均满足测定要求。辅酶Q₁₀原料所含元素杂质均远低于限度值，企业1~3生产的辅酶Q₁₀胶囊含Pb浓度较高。企业3、14生产的辅酶Q₁₀胶囊含（Al）浓度较高，有可能是药用辅料滑石粉引入。结论：所用方法准确快捷，灵敏度高，适用于辅酶Q₁₀原料和制剂中元素杂质的测定。

Objective:To establish a method for determination of twenty-two elemental impurities in coenzyme Q₁₀ material and preparations. Methods:A rapid method was established based on microwave digestion assisted with inductively coupled plasma-mass spectrometer (ICP-MS) for full quantitative analysis for Cd, Pb, As, Hg, Co, V, Ni and semi quantitative analysis for other 15 elemental impurities. Results:The recoveries of Cd, Pb, As, Hg, Co, V, Ni in coenzyme Q₁₀ were 89.8%-10³.5%, and the limits of detection all met the requirements of determination. The elemental impurities in coenzyme Q₁₀ material were far below limits. The concentrations of lead in coenzyme Q₁₀ capsules made by manufacturers 1-3 were higher than the other. The higher concentration of aluminum in coenzyme Q₁₀ capsules made by manufacturers 3 and 14 were supposed come from pharmaceutical excipient talc. Conclusion:The proposed method is accurate, rapid, and sensitive, which can be applied to the determination of elemental impurities in coenzyme Q₁₀ material and preparations.

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