摘要
目的:对注射用奥沙利铂有关物质检查法中发现的问题进行探讨。方法:参照EP 6.0和BP(2005年版)杂质C检查方法(HPLC法)的流动相[以磷酸溶液-乙腈(99∶1)],对检出波长、色谱柱进行了筛选,以确定的色谱条件对奥沙利铂的降解产物、检测限进行检测,并与现有国家标准方法[HPLC法,以甲醇-水(9∶1)为流动相,检测波长为250 nm]进行比较。结果:采用EP 6.0和BP(2005年版)奥沙利铂杂质C检查方法对注射用奥沙利铂的杂质进行检查,其杂质检出率明显高于现有国家标准。结论:现有国家标准不能有效地对奥沙利铂杂质进行检出,因而对注射用奥沙利铂有关物质检查方法需重新论证,给出更合理有效的检查方法。
Objective :To study the method on impurities test of oxaliplatin for injection. Method:By referring to the test for oxaliplatin impurity C in EP 6.0 or BP 2005 [ HPLC, mobile phase was phosphoric acid solution - acetonitrile(99: 1 )], and screening the detection wavelength and chromatogram column, a primary method was established. Simultaneously, the degradation products and determination limit in oxaliplatin were detected by it, comparing with the state standard in existence [ HPLC, mobile phase was methanol - water(9:1 ), detection wavelength was 250 nm]. Results: Adopting the method for oxaliplatin impurity C in EP 6.0 or BP 2005,it was found that the detection rate of impurities was higher than that of state standard. Conclusions: The impurities of oxaliplatin for injection can hardly be detected effectively by the method of state standard in existence. Therefore a newly efficient method was expected after the old one was argumented again.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2009年第11期1850-1853,共4页
Chinese Journal of Pharmaceutical Analysis