| 高效液相色谱法测定依达拉奉注射液的含量及其有关物质 |
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| 引用本文： | 汤海燕,朱正怡,叶肖栗.高效液相色谱法测定依达拉奉注射液的含量及其有关物质[J].海峡药学,2010,22(5):77-78. |
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| 作者姓名： | 汤海燕 朱正怡 叶肖栗 |
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| 作者单位： | 浙江大学医学院附属儿童医院药剂科,杭州,310003 |
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| 摘 要： | 目的建立测定依达拉奉注射液含量及有关物质的高效液相色谱法。方法采用Shimadzu ODS-C18柱（4.6mm×150mm,5μm）;流动相：甲醇-0.015mol·L^-1磷酸二氢钠-三乙胺（35∶65∶0.1）混合后,用磷酸调pH为6.0±0.5;检测波长239nm;流速为1.0mL·min^-1;柱温：35℃。结果在建立的色谱条件下,依达拉奉与样品中杂质分离完全;在0.14-1.11 mg·mL^-1范围内,峰面积与其浓度线性关系良好（r=0.9999）;平均回收率为100.36%（RSD=0.41%,n=9）;最低检出量为0.024ng。结论本法简便快速,准确可靠,可用于依达拉奉注射液的质量控制。
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| 关 键 词： | 依达拉奉 HPLC 有关物质 含量测定 |
Determination of the content and the related substances of edaravone by HPLC |
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| TANG Hai-yan,ZHU Zheng-yi,YE Xiao-li.Determination of the content and the related substances of edaravone by HPLC[J].Strait Pharmaceutical Journal,2010,22(5):77-78. |
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| Authors: | TANG Hai-yan ZHU Zheng-yi YE Xiao-li |
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| Institution: | (Department of pharmacy,children＇s Hospital offiliated of Zhejiang University School of medicine Hangzhou) |
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| Abstract: | OBJECTIVE To establish an HPLC method for the determination of edaravone injection and its related substance.METHODS A Shimadzu ODS-C18 column（4.6mm×150mm,5μm） was adopted.The mobile phase were methanol-0.015mol·L^-1 sodium dihydrogen phosphate-triethylamine（35∶65∶0.1,adjusted to pH 6.0±0.5 with phosphoric acid） at a flow rate of 1.0mL·min^-1,detection was done at 239nm.RESULTS Under the described chromatographic condition,edaravone was completely separated from its impurities.Edaravone had a good linear relation in the range of 0.14～1.11 mg·mL^-1（r=0.9999）.The average recovery was 100.36%（RSD=0.41%,n=9）,and the lowest detectable amount was 0.024ng.CONCLUSION The method can be used for quality control of edaravone injection and its related substance,it is accurate,simple and convenient. |
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| Keywords: | HPLC |
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