RP-HPLC法测定布洛芬丁香酚酯微乳中布洛芬丁香酚酯及有关物质含量

Determination of content and related substances of ibuprofen eugenol ester in microemulsion by RP-HPLC

目的 测定布洛芬丁香酚酯（ibuprofen eugenol ester）微乳中布洛芬丁香酚酯及有关物质的含量。方法 微乳用甲醇溶解，采用RP-HPLC法。色谱柱：ODS色谱柱；流动相：甲醇-体积分数为0．2％的三氟乙酸-四氢呋喃（体积比为170：20：15）；流速：1．0mL·min^-1；检测波长：230nm；室温测定。结果 RP-HPLC法测定的线性范围为0．5～50mg·L^-1，相关系数r=0．9998；微乳中布洛芬丁香酚酯的平均回收率为99．95％（RSD=0．35％，n=9）；最低检测限50ng；重复性良好（RSD=0．71％）。结论 该方法适用于布洛芬丁香酚酯及有关物质的含量测定。

Objective To determine the contents and the related substances of ibuprofen eugenol ester in microemulsion. Methods A RP-HPLC method was used. The mobile phase consisted of methanol-0.2 % trifluoroacetic acid-tetrahydrofuran（ V ： V ： V = 170 ： 20 ： 15）, at a flow rate of 1.0 mL·min^- 1. The test was operated at room temperature. The determination wavelength was set at 230 nm. The microemulsion was dissolved with methanol. Results The linear clibration curves was obtained in the range of 0.5 - 50 mg·L^-1 （r = 0.999 8）. The average recovery of ibuprofen eugenol ester was 99.95 % （RSD = 0.35 % ） in microemulsion. The detection limit was 50 ng, The precision of the method（RSD = 0.71%）was good. Conclusions The method is proved to be suitable for detection of the content and the related substances of ibuprofen eugenol ester in microemulsion, which offers the advantages of specifity, speed and sensitivity.