摘要
目的建立测定依达拉奉注射液中依达拉奉及有关物质含量的高效液相色谱法(HPLC)。方法采用Cro-masilC18柱(250mm×4.6mm,5μm),流动相:甲醇-0.05mol/L磷酸二氢铵溶液(50:50)[用20%磷酸调节pH值至(3.5±0.1)];流速:1.0ml/min;检测波长:239nm;柱温:30℃。结果在该色谱条件下,依达拉奉与样品中杂质可完全分离;在6.024～54.216μg/ml范围内,峰面积与其浓度线性关系良好(r=0.9997,n=5),平均回收率为100.34%(RSD=0.55%,n=9),最低检出量为12.1ng。结论本法操作简便快速,准确可靠,专属性强,可用于依达拉奉注射液中依达拉奉及有关物质的测定。
Objective To establish an high performance liquid chromatography （HPLC） for the determination of edaravone injection and its related substances. Methods The Cromasil C18 （250 mm×4.6 mm,5 μm）column was used.The mobile phase was methanol -0.05 mol/L ammonium dihydrogen phosphate solution （50：50） [adjust to pH （3.5 ±0.1） with 20% phosphoric acid],the flow rate was 1.0 m/min and the detection wavelength was at 239 nm,the column temperature was 30℃. Results Under the described chromatographic condition,edaravone was completely separated from its impurities.Edaravone had a good linear relation in the range of 6.024-54.216 μg/ml（r = 0 9997, n = 5）.The average recovery was 100.34% （RSD = 0.55%, n = 9）, and the lowest detectable amount was 12.1 ng.Conclusion The method can beused for quality control of edaravone injeetion and its related substance ,it is accurate,simple and convenient.
出处
《中国当代医药》
2013年第21期61-63,65,共4页
China Modern Medicine
关键词
依达拉奉
HPLC
含量测定
有关物质
Edaravone
High performance liquid chromatography
Content determination
Related substance
