| 多索茶碱注射液的含量测定方法改进 |
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| 引用本文： | 郭旭光,郑子栋. 多索茶碱注射液的含量测定方法改进[J]. 中国药事, 2014, 0(7): 774-777 |
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| 作者姓名： | 郭旭光 郑子栋 |
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| 作者单位： | 河南省食品药品检验所,郑州450003 |
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| 摘 要： | 目的 对多索茶碱注射液含量测定方法进行改进,为该药品质量标准修订提供参考.方法 采用高效液相色谱法,色谱柱为Agela Venusil ASB C18,流动相为乙腈-水（35∶65）,流速为1.0 mL·min^-1,检测波长为273 nm,柱温为30℃.结果 多索茶碱在0.2003～0.8012μg范围内与峰面积线性关系良好（r=0.9998）;平均回收率为99.8％,RSD为0.5％（n=9）.结论 该方法经方法学验证可用于多索茶碱注射液的含量及有关物质测定.
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| 关 键 词： | 多索茶碱注射液 含量测定 有关物质 标准修订 高效液相色谱法 |
Simultaneous Determination of Doxofylline Injection and Its Related Substances by HPLC |
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| Guo Xuguang and Zheng Zidong. Simultaneous Determination of Doxofylline Injection and Its Related Substances by HPLC[J]. Chinese Pharmaceutical Affairs, 2014, 0(7): 774-777 |
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| Authors: | Guo Xuguang and Zheng Zidong |
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| Affiliation: | Guo Xuguang and Zheng Zidong (Henan Provincial Institute of Food and Drug Control, Zhengzhou 450003) |
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| Abstract: | Objective To improve the method of content determination of Doxofylline Injection, and provide a reference for revision of the drug quality standard. Methods The Agela Venusil ASB C18 was used, the mobile phase consisted of aeetonitril-water （35 ： 65）, the flow rate was 1.0 mL · min^-1 , the detection wavelength was 273 nm, the column temperature was at 30 ℃. Results The calibration curve of doxofylline was in good linearity over the range of 0. 2003-0. 8012μg. The average recovery was 99.8% with RSD 0.5% （n=9）. Conclusion The method is simple, accurate, and reliable, which can be used for the determination of Doxofylline Injection and its related substances. |
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| Keywords: | Doxofylline Injection determination related substances standard revision HPLC |
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