HPLC法测定布洛芬原料及制剂的有关物质

HPLC determination of substance and related substances for the preparation of ibuprofen

目的:为了完善布洛芬的有关物质检查方法,使其更适用于中国的实际生产情况。方法:采用高效液相色谱法,紫外检测器,十八烷基硅烷键合硅胶柱,固定相:phenomenex C18(4.6 mm×250 mm,5μm),流动相:乙腈-水(用磷酸调节pH为3.0)(1∶1),检测波长:254 nm。结果:3种已知杂质和布洛芬及其他未知杂质均能得到有效分离;3种已知杂质在2～50μg.mL-1范围内线性关系良好,r分别为0.9999,1.0000,0.9999,平均回收率分别为99.7%,99.5%,100.1%。结论:本方法灵敏、准确、可靠,能够准确测定布洛芬原料及制剂的有关物质。

Objective： To perfect the determination method of the related substances in ibuprofen,for its adaptability to our country.Methods：Three related substances of ibuprofen are determinated by HPLC.Waters Symmetry ShieldTM C18（4.6 mm×250 mm,5 μm） was used with mobile phase consisted of acetonitrile-water（adjusted pH to 3.0 with phosphoric acid）（1∶1）.The detective wavelength was set at 254 nm.Results： In the determination of related substances by HPLC,the linearity were good within the range 2-50 μg·mL-1,and the regression coefficient were 0.9999,1.0000,0.9999,respectively,while the recoveries were 99.7%,99.5%,100.1%,respectively.Conclusion： This method is operated easily,and it can be used to accurately determinate the related substances contend in ibuprofen.