药用辅料甘油三乙酯中7种ICH控制元素测定方法的建立

Determination of 7 elements in pharmaceutical excipient triacetin by ICH requirement

目的建立电感耦合等离子体质谱法(ICP-MS)测定药用辅料甘油三乙酯中钒(V)、钴(Co)、镍(Ni)、砷(As)、镉(Cd)、铅(Pb)、汞(Hg)元素的含量。方法样品经微波消解处理后,按拟订的仪器工作条件,采用ICP-MS法进行测定,并通过在线加入内标元素来校正测量结果。结果各元素在1~50 ng·mL^(-1)与响应值线性关系良好(r在0.998~0.999);回收率均在80.7%~105.8%(n=6)。结论本方法准确度高、重现性好,可用于药用辅料甘油三乙酯中多种元素杂质的含量测定。

Objective To establish the inductively coupled plasma mass spectrometry(ICP-MS)to determine V,Co,Ni,As,Cd,Pb and Hg in pharmaceutical excipient triacetin.Methods The elements in triacetin were determined by ICP-MS after the microwave digestion treatment.The measurement results were corrected through online adding the internal standard solution.Results The standard curves showed good linearity(r was 0.998~0.999).The recovery was 80.7%~105.8%(n=6).Conclusion The method has good accuracy and reproducibility,and can be used for the determination of element impurities in pharmaceutical excipient triacetin.