加校正因子的主成分自身对照法同时测定奥沙利铂中2种有关物质的含量

Main component with correction factor self-comparison method for the simultaneously determination of 2 related substances in oxaliplatin

目的建立加校正因子的主成分自身对照法测定奥沙利铂中有关物质的含量。方法采用Syncronis aQ-C18(4.6 mm×250 mm,5μm)色谱柱;流动相为乙腈-0.001 mol·L-1磷酸溶液(pH 3.0)(1∶99);流速为1.0 mL·min-1;检测波长为205 nm;柱温为25℃;进样量为10μL。测定奥沙利铂与二氯二氨环己烷铂、双羟基奥沙利铂的标准曲线方程,以斜率计算有关物质相对于奥沙利铂的校正因子,用相对保留时间确定各有关物质的位置。结果二氯二氨环己烷铂、双羟基奥沙利铂的相对保留时间分别为0.83与0.51,相对校正因子分别为0.81与0.14。结论本方法可用于奥沙利铂中有关物质的定性及定量分析,可以准确地反映其有关物质的含量。

Objective To determine the content of related substances in oxaliplatin by the main component with correction factor self-comparison method.Methods The separation was performed on a Syncronis aQ-C18(4.6 mm×250 mm,5μm)column.The mobile phase was acetonitrile-0.001 mol·L-1 phosphoric acid solution(pH 3.0)(1∶99)at 1.0 mL·min-1.The detection wavelength was 205 nm,the column temperature was 25℃,and the injection volume was 10μL.The slope of linear equation was used to determine the relative correction factor between 2 related substances and oxaliplatin.The relative retention time was used to determine the position of related substances.Results The relative retention time of the 2 related substances was 0.83 and 0.51,respectively.The relative correction factors of the 2 related substances were 0.81 and 0.14,respectively.Conclusion The method can be used for the qualitative and quantitative analysis of the related substances in oxaliplatin and reflect the content of related substances more accurately.