电感耦合等离子体质谱法测定注射用美罗培南中的13个元素杂质

Study on the determination of 13 elemental impurities in meropenem for injection by ICP-MS

目的 建立电感耦合等离子体质谱(ICP-MS)法测定注射用美罗培南中Li、V、Co、Ni、Cu、Zn、As、Rh、Pd、Cd、Sb、Hg和Pb共13个元素杂质含量。方法 供试品经直接稀释后采用ICP-MS法对13个金属元素进行分析测定。以Be、Ge、In、Bi元素为内标校正基体效应和漂移。结果 13个元素在各自的检测浓度范围内线性关系良好(r≥0.9997);各浓度点平均回收率为89.2%~114.5%(n=3);重复性为2.3%~4.6%(n=6),中间精密度为2.9%~5.7%(n=12),均满足USP 43<233>方法学验证的要求。不同厂家的注射用美罗培南中13种元素杂质含量均符合ICH规定。结论 本方法操作简单、分析速度快,准确性好、灵敏度高,可用于注射用美罗培南中元素杂质的质量控制。

Objective To establish an inductively coupled plasma mass spectrometry(ICP-MS) method for simultaneous determination of 13 elemental impurities(Li, V, Co, Ni, Cu, Zn, As, Rh, Pd, Cd, Sb, Hg, and Pb) in meropenem for injection. Methods The samples were diluted with 2% nitric acid directly and then the 13 elements in the solution were analyzed by ICP-MS. The Be, Ge, In, and Bi were used as internal standards for matrix effect correction. Results The 13 elements showed good linearity in the specified concentration range with the correlation coefficients(r)being all above 0.9997. The recoveries were between 89.2%~114.5%(n=3). The repeatability and intermediate precision were between 2.3%~4.6%(n=6)and 2.9%~5.7%(n=12),respectively, which all met the acceptance criteria of USP 43<233>. The elemental impurities in meropenem for injection from different manufactures complied with ICH requirements. Conclusion The established ICP-MS method was simple, rapid, accurate, and sensitive, and could be used for elemental impurity control of meropenem for injection.