目的:建立米铂原料药中光学异构体杂质的定性及定量研究。方法:利用高效液相色谱法,采用主成分自身对照法对光学异构体杂质进行定量分析。结果:米铂在浓度0.2066~41.32μg·m L-1,S,S异构体(杂质A)在浓度0.199 2~39.84μg·m L-1范围内,R,S异构体(杂质B)在浓度0.195 8~39.16μg·m L-1,浓度与峰面积线性关系良好,并且米铂,R,S异构体和S,S异构体的定量限(S/N=10)分别为10.33,9.79,9.96 ng;检测限(S/N=3)分别为5.16,4.90,4.98 ng。结论:本研究建立的主成分自身对照法灵敏度高,重复性好,适用于米铂原料中光学异构体杂质的定性定量分析。 Objective: To establish a qualitative and quantitative study of impurities of optical isomers in mplatin. Methods: The impurities of optical isomers were quantitatively analyzed by high performance liquid chromatography and the principal component self-control method. Results: The concentrations of mplatin in the range of 0.2066 ~ 41.32μg · m L-1, S, S isomers (impurity A) in the range of 0.199 2 ~ 39.84μg · m L-1, ) Had a good linear relationship between concentration and peak area at concentrations of 0.195 8 ~ 39.16 μg · m L-1, and the limit of quantification (S / N = 10) of the moplatin, R, S isomers and S, S isomers The detection limits (S / N = 3) were 5.16, 4.90 and 4.98 ng, respectively. Conclusion: The principal components established by this study have high sensitivity and good reproducibility, and are suitable for qualitative and quantitative analysis of optical isomers impurities in mplatin.