关于注射用奥沙利铂有关物质检查方法的探讨___
Approach on impurities test of oxaliplatin for injection
分类号：
出版年·卷·期（页码）：2009,29 (11):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
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-----英文摘要：---------------------------------------------------------------------------------------
Objective: To study the method on impurities test of oxaliplatin for injection. Method: By referring to the test for Oxaliplatin impurity C in EP6.0 or BP2005(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.
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1 EP .6.0 .2574
2 BP .2005.1476
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