布洛芬及其制剂中有关物质的分析  

Analysis of related substances in ibuprofen and its preparations

作　　者：陈静[1] 余丽[1] 晁若冰[1] 

机构地区：[1]四川大学华西药学院,成都610041

出　　处：《药物分析杂志》2011年第8期1480-1484,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立高效液相色谱法测定布洛芬及其制剂中的有关物质。方法:采用Kromasil C18色谱柱,以甲醇-乙腈-水-甲酸(50∶9∶41∶0.02)为流动相,流速1.0m·Lmin-1,检测波长为214nm。结果:在选定的条件下,布洛芬与其中的10余种杂质分离良好;布洛芬和杂质4-异丁基苯甲酸、4-异丁基苯乙酮的检测限分别为0.16μg·mL-1、0.093μg·mL-1、0.18μg·mL-1;布洛芬在4～64μg·mL-1,4-异丁基苯甲酸和4-异丁基苯乙酮在0.4～6.4μg·mL-1范围内峰面积与浓度呈良好的线性关系;以布洛芬为参比,测得以上2种杂质的校正因子分别为1.68和0.77。结论:本法简便、专属、准确,可用于布洛芬及其制剂中有关物质的检查。Objective：To establish an HPLC method to determine the related substances of ibuprofen and its preparations.Method：The HPLC method was performed on a Kromasil C18column with the mobile phase of methanol-acetonitrile-water-formic acid（50∶ 9∶ 41∶ 0.02） at the flow rate of 1.0 mL·min-1,and the detection wavelength was set at 214 nm.Result：Under the described chromatographic condition,ibuprofen was completely separated from the related substances.The LOD of ibuprofen,[4-（2-methylpropyl）phenyl]formic acid and 1-[4-（2-methyl propyl） phenyl]ethanone were 0.16 μg·mL-1,0.093 μg·mL-1 and 0.18 μg·mL-1,respectively.The linear ranges of ibuprofen and the impurities were 4-64 μg·mL-1 and 0.4-6.4 μg·mL-1,respectively.And the correction factors of the impurities were 1.68 and 0.77,respectively.Conclusion：The method is simple,specific,accurate and suitable for analysing the related substances in ibuprofen and its preparations.

关 键 词：非甾体消炎药 布洛芬 原料 制剂 有关物质 杂质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]