米铂原料中光学异构体杂质研究

发布时间：2018-07-16 07:50

【摘要】：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。
[Abstract]:Objective: to establish a qualitative and quantitative study on the optical isomer impurity in Miplatin. Methods: the optical isomer impurity was quantitatively analyzed by HPLC and principal component self-control method. Results: the concentration of Miplatin was 0.199 ~ 39.84 渭 g m ~ (-1) in the concentration range of 0.2066 ~ 41.32 渭 g m ~ (-1) ~ (-1) and the concentration of impurity B was in the range of 0.195 ~ 8 ~ 39.16 渭 g ~ (-1) 渭 g / L ~ (-1). The linear relationship between the concentration and the peak area was good. The quantification limits (S / N ~ (10) and the detection limits (S / N ~ (3) of the r-S isomers and the S / N _ (10) were 10.33 / 9.79 / 9.96 ng and 5.16 / 4.90 / 4.98 ng / g, respectively. Conclusion: the principal component self-control method developed in this study has high sensitivity and good reproducibility and is suitable for qualitative and quantitative analysis of optical isomer impurities in rice platinum raw materials.
【作者单位】：黑龙江大学功能有机重点实验室;黑龙江大庆油田总医院集团让北医院;国药一心制药有限公司;
【基金】：黑龙江省教育厅科学技术研究项目(12521417)
【分类号】：R927;O657.72

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