HPLC法测定布洛芬原料及制剂的有关物质

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,5 μm),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2~50 μg·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 Shield^TM 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.