摘要
目的建立以高效液相色谱法测定注射用奥沙利铂主药含量的方法。方法色谱柱为C18,流动相为甲醇-水(5∶95),流速为110mL/min,柱温为25℃,检测波长为250nm,进样量为20μL。结果奥沙利铂检测浓度的线性范围为5～1715μg/mL(r=0.9999),检测限为3ng(S/N=3),3批原料药及其制剂中主药平均含量分别为0.081%、0.15%。结论本方法准确、可靠、操作性强,可用于奥沙利铂中主药含量测定。
Objective To establish the HPLC method for the determination of the related substances in oxali platin. Methods The chromatographicseparation was performed on C-18,and the mobile phasec onsistedofmethylal cohol and water（5：95）with a flow rate of 1.0mL/min.ResultsThe average contentin 3 batches of cruded rug vsl their preparations was 0.081% vs 0.15 %. Conclusion This method is accurate,reliable and available,and suitable for the contented termination of the related substances in oxali platin.
出处
《中外医疗》
2009年第14期14-14,共1页
China & Foreign Medical Treatment
