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  

Determination of the content and the related substances of edaravone by HPLC

作　　者：汤海燕[1] 朱正怡[1] 叶肖栗[1] 

机构地区：[1]浙江大学医学院附属儿童医院药剂科,杭州310003

出　　处：《海峡药学》2010年第5期77-78,共2页Strait Pharmaceutical Journal

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。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.

关 键 词：依达拉奉 HPLC 有关物质 含量测定 

分 类 号：R927.2[医药卫生—药学]