| HPLC法测定奥赛博司原料药中有关物质的含量 |
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| 引用本文： | 陈毓杰,刘培勋,洪阁,李琪.HPLC法测定奥赛博司原料药中有关物质的含量[J].中国药房,2009(19):1495-1497. |
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| 作者姓名： | 陈毓杰 刘培勋 洪阁 李琪 |
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| 作者单位： | 中国医学科学院北京协和医学院放射医学研究所,天津市300192 |
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| 基金项目： | 天津市科技计划项目（07ZCKFSH00200） |
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| 摘 要： | 目的:建立以高效液相色谱法测定奥赛博司原料药中有关物质含量的方法。方法:色谱柱为SunFireTMRP C18,流动相为磷酸盐缓冲溶液(pH3.05)-乙腈(8∶2),流速为1mL.min-1,检测波长为220nm,进样量为20μL,柱温为室温。结果:3批原料药经破坏试验后奥赛博司主峰与其它杂质峰均分离较好,有关物质含量均小于1.19%。结论:本方法简便、灵敏度高,可用于奥赛博司有关物质的含量检测。
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| 关 键 词： | 高效液相色谱法 奥赛博司 有关物质 含量 |
Determination of the Related Substances in Aosaibos Crude Drug by HPLC |
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| CHEN Yu-jie,LIU Pei-xun,HONG Ge,LI Qi.Determination of the Related Substances in Aosaibos Crude Drug by HPLC[J].China Pharmacy,2009(19):1495-1497. |
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| Authors: | CHEN Yu-jie LIU Pei-xun HONG Ge LI Qi |
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| Institution: | (Institute of Radiation Medicine, Peking Union Medical Col- lege of Chinese Academy of Medical Sciences, Tianjin 300192, China) A |
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| Abstract: | OBJECTIVE： To determine the contents of the related substances in Aosaibos crude drug by HPLC. METH- ODS： The determination was carried out on a SunFireTM RP C18 column with mobile phase consisted of phosphate buffer solution （pH 3.05） - acetonitrile （8 ： 2） at a flow rate of 1 mL ·min -5. The detection wavelength was set at 220 nm; The sample size was 20μL and column temperature was set at room temperature. RESULTS： The main peak and the impurity peaks of 3 batchs of Aosaibos crude drug were well- separated. The contents of the related substances were all lower than 1.19%. CONCLUSION： The determination method is simple, sensitive and applicable for the content determination of the related substances of Aosaibos. |
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| Keywords: | HPLC Aosaibos Related substances Content |
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