Determination of 23 elemental impurities in nedaplatin for injection,nedaplatin and excipients by ICP-MS
Objective:To establish an ICP-MS method for the determination of 23 potential risk elemental im-purities including As,Cd,Hg,Pb,Co,Ni,V,Ag,Au,Ir,Os,Pd,Rh,Ru,Se,Tl,Ba,Cr,Cu,Li,Mo,Sb,Sn in nedaplatin for injection,nedaplatin and excipients.Methods:Inductively coupled plasma mass spec-trometry(ICP-MS)was used to establish a method for the contents of 23 elemental imputities in nedaplatin for in-jection,nedaplatin and excipients,and relevant methodological validation were carried out.The samples were pre-treated by directly dissolution.Results:The method simultaneously determined 23 elemental impurities.The re-sponse values of the 23 elemental impurities showed a good linear relationship with their mass concentrations(r≥0.99).The relative standard deviations(RSDs)of the repeatability tests were less than 9％(n=6),and the av-erage recovery rates ranged from 94％to 116％(n=9),which all met the requirements of methodological valida-tion.The contents of 23 elemental impurities in total 16 batches from 4 manufacturers of nedaplatin for injection were all below 30％of the limits specified by ICH Q3D.Conclusion:The established ICP-MS method is simple,sensitive,accurate,and has good specificity and repeatability.It can be used as a quality control detection method for 23 elemental impurities in the platinum based anti-tumor drug substances and products.
elemental impuritiesnedaplatin for injectionICP-MSrisk assessment
万方数据
维普
