关于注射用奥沙利铂有关物质检查方法的探讨

Approach on test of related substances in oxaliplatin for injection

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.