HPLC法测定布洛芬注射液的含量及有关物质  

Determination of Ibuprofen and its Related Substances in Injection by HPLC

作　　者：丁洪亮[1] 

机构地区：[1]江苏省宜兴市人民医院,宜兴214200

出　　处：《药学与临床研究》2010年第6期583-584,共2页Pharmaceutical and Clinical Research

摘　　要：目的:建立布洛芬注射液的含量和有关物质的HPLC测定法。方法:以醋酸钠缓冲液(冰醋酸调节pH值至2.5)-乙腈(40︰60)为流动相,检测波长为263 nm,测定布洛芬含量及有关物质(4-异丁基苯乙酮)。结果:布洛芬在400～600μg.mL-1浓度范围内线性关系良好,r=0.9992,平均回收率为99.07%(n=9);4-异丁基苯乙酮检测限为0.1 ng,与布洛芬分离良好。结论:该方法准确可靠,专属性强,可以满足制剂质量控制的要求。Objective： To establish an HPLC method for the determination of the content of ibuprofen and its related substances in injection.Methods： The separation was performed on C18 column.The mobile phase was composed of sodium acetate buffer（adjusted to pH 2.5 with acetic acid）-acetonitrile（40︰60）,and the detection wavelength was set at 263nm.Results： A linearity between peak areas and ibuprofen concentration was achieved in the range of 400～600μg·mL-1,with r=0.9992.The average recovery was 99.07%（n=9）.The detection limit of 4-isobutyl acetophenone was 0.1 ng.Conclusion： The method is reliable,specific and accurate,which can be used for quality control of ibuprofen injection.

关 键 词：布洛芬 4-异丁基苯乙酮 HPLC法 含量测定 有关物质 

分 类 号：R927.2[医药卫生—药学]