| HPLC法测定盐酸吉西他滨的有关物质 |
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| 引用本文： | 赵军军,李孝壁,马平平,孔双华,杨宝海,王春玲. HPLC法测定盐酸吉西他滨的有关物质[J]. 中国医药科学, 2012, 0(18): 106-108 |
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| 作者姓名： | 赵军军 李孝壁 马平平 孔双华 杨宝海 王春玲 |
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| 作者单位： | 江苏豪森医药研究院有限公司 |
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| 摘 要： | 目的改进盐酸吉西他滨有关物质的测定方法。方法采用迪马C8(250mm×4.6mm,5μm)色谱柱,梯度洗脱检查,流速为1.0mL·min-1,检测波长275nm。结果在0.005～2.402μg/mL范围线性关系良好,相关系数r>0.999(n=5),重复性试验的RSD<0.0005%(n=6)。结论本方法简单、准确、重现性好,可用于盐酸吉西他滨的有关物质检查。
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| 关 键 词： | 盐酸吉西他滨 有关物质 HPLC |
Determination of gemcitabine hydrochloride and its related substances by HPLC |
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| ZHAO Junjun,LI Xiaobi,MA Pingping,KONG Shuanghua,YANG Baohai,WANG Chunling. Determination of gemcitabine hydrochloride and its related substances by HPLC[J]. China Medicine and Pharmacy, 2012, 0(18): 106-108 |
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| Authors: | ZHAO Junjun LI Xiaobi MA Pingping KONG Shuanghua YANG Baohai WANG Chunling |
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| Affiliation: | Jiangsu Hansoh Medicine Research Institute Co.,Ltd,Lianyungang 222000,China |
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| Abstract: | Objective To improve the determination of related substances in gemcitabine hydrochloride. Methods The determination was carried out on a Dikma C8(250 mm×4.6 mm,5μm)column with gradient elution.The detection wavelength of UV detector was 275 nm. Results There was a good linearity over the range of 0.005-2.402μg/mL with a the correlation coefficient higher than 0.999(n=5).The RSD for repeatition was less than 0.0005%(n=6). Conclusion The method was simple,accurate and good reproducibility,which can be used for the determination of related substances for gemcitabine hydrochloride. |
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| Keywords: | Gemcitabine hydrochloride Related substances HPLC |
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