| HPLC法测定单硝酸异山梨酯中山梨醇和脱水山梨醇含量 |
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| 引用本文： | 周庆英,李洪伟,马丽.HPLC法测定单硝酸异山梨酯中山梨醇和脱水山梨醇含量[J].齐鲁药事,2011,30(9):513-514,529. |
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| 作者姓名： | 周庆英 李洪伟 马丽 |
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| 作者单位： | 1. 临沂市药品检验所,山东,临沂,276000
2. 鲁南制药集团股份有限公司,山东,临沂,276006 |
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| 摘 要： | 目的建立了高效液相色谱法测定单硝酸异山梨酯中山梨醇和脱水山梨醇含量的方法.方法采用ThermoAps-2HypersilNH2柱(250mm×4.6mm,5μm);流动相:乙腈-水(6∶1);流速为1.0mL·min-1;柱温30℃;检测波长195 nm.结果通过对山梨醇和脱水山梨醇的实验,确定了山梨醇检测限为0.51μg,脱水山梨醇检测限为0.013μg,线性范围、精密度及回收率良好.结论该方法的建立为生产过程中快速检测单硝酸异山梨酯中山梨醇和脱水山梨醇含量提供了可靠的分析平台,可用于单硝酸异山梨酯的实际检验工作和产品质量控制.
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| 关 键 词： | 单硝酸异山梨酯 山梨醇 脱水山梨醇 高效液相色谱 含量测定 |
Determination of glucitol and anhydro-glucitol in isosorbide mononitrate by HPLC |
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| ZHOU Qing-ying,LI Hong-wei,MA Li.Determination of glucitol and anhydro-glucitol in isosorbide mononitrate by HPLC[J].qilu pharmaceutical affairs,2011,30(9):513-514,529. |
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| Authors: | ZHOU Qing-ying LI Hong-wei MA Li |
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| Institution: | ZHOU Qing-ying1,LI Hong-wei2,MA Li2(1.Linyi Institute for Drug Control,Linyi 276000,China,2.Lunan Pharmaceutical Group Co.,Ltd.,Linyi 276006,China) |
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| Abstract: | Objective To establish an HPLC method for the determination of glucitol and anhydro-glucitol in isosorbide mononitrate.Methods Thermo Aps-2 Hypersil NH2 Column（250 mm×4.6 mm,5 μm） was adopted with acetonitrile-water（6∶ 1） as mobile phase at a flow rate of 1.0 mL·min-1.The column temperature was 30 ℃ and the detection wavelength was 195 nm.Results With the method,the detection limit of glucitol was 0.51 μg and the detection limit of anhydro-glucitol was 0.013 μg.The linear range,precision and recovery were relatively good.Conclusion The method provided a reliable analysis platform for rapidly determining the glucitol and anhydro-glucitol in isosobide mononitrate in process of production,and can be used for the actual test and quality control of isosorbide mononitrate. |
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| Keywords: | Isosorbide mononitrate Glucitol Anhydro-glucitol HPLC Determination |
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