| HPLC测定丹参素冰片酯脂肪乳注射液含量及有关物质 |
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| 引用本文： | 刘海静,王雨轩,李霞,张亚军,惠民权,郑晓晖.HPLC测定丹参素冰片酯脂肪乳注射液含量及有关物质[J].药物分析杂志,2012(5):788-792. |
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| 作者姓名： | 刘海静 王雨轩 李霞 张亚军 惠民权 郑晓晖 |
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| 作者单位： | 陕西省食品药品检验所;陕西中医学院;西北大学中草药现代化研究及工程中心 |
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| 基金项目： | 科技部国家“十一五”规划重大新药创制专项课题(项目编号:2009ZX09103-121);陕西省“13115”科技创新工程重大科技专项(项目编号:2007ZDKG-70) |
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| 摘 要： | 目的:建立丹参素冰片酯脂肪乳注射液含量测定及有关物质检查方法。方法:采用高效液相色谱法。色谱柱:KromasilC18(150 mm×4.6 mm,5μm)色谱柱,流动相:乙腈-0.2%甲酸水(42︰58),流速为1.0 mL·min-1,检测波长280 nm,进样体积20μL。结果:试验结果表明,HPLC法检测主峰与杂质峰有较好的分离度,且重复性较好;丹参素冰片酯的浓度在5～60μg·mL-1范围内与峰面积呈良好线性关系(r=1.000),平均回收率为98.2%(n=9)。结论:该法操作简便,结果可靠,适用于丹参素冰片酯脂肪乳注射液含量测定及有关物质检查。
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| 关 键 词： | 高效液相色谱法 丹参素冰片酯 脂肪乳注射液 静脉给药制剂 含量测定 有关物质 |
HPLC determination of content and related substances of Danshensu Borneol Ester fat emulsion injection |
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| LIU Hai-jing,WANG Yu-xuan,LI Xia,ZHANG Ya-jun,HUI Min-quan,ZHENG Xiao-hui.HPLC determination of content and related substances of Danshensu Borneol Ester fat emulsion injection[J].Chinese Journal of Pharmaceutical Analysis,2012(5):788-792. |
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| Authors: | LIU Hai-jing WANG Yu-xuan LI Xia ZHANG Ya-jun HUI Min-quan ZHENG Xiao-hui |
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| Institution: | 1.Shaanxi Institute for Food and Drug Control,Xi’an 710061,China;2.Shaanxi University of Chinese Medicine,Xianyang 712046,China;3.Engineering and Research Center of Chinese Herb Modernization,Northwest University,Xi’an 710069,China) |
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| Abstract: | Objective:To establish a method to determine the content and related substances of Danshensu Borneol Ester fat emulsion injection.Methods: The experimental conditions were as follows: Kromasil C18 column(150 mm×4.6 mm,5 μm),acetonitrile-0.2% formic acid in water(42︰58) as mobile phase,the flow rate: 1.0 mL·min-1,the injection volume: 20 μL,and detection wavelength was set at 280 nm.Results: The main peak and impurity peaks have good resolution and repeatability.The calibration curve was linear in the range of 5-60 μg·mL-1(r=1.000).The average recovery was 98.2%(n=9).Conclusion: The method is simple,rapid,sensitive and accurate.It is suitable for determination of the content and related substances of Danshensu Borneol Ester fat emulsion injection. |
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| Keywords: | HPLC Danshensu Borneol Ester fat emulsion injection intravenous drug preparation assay related substances |
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