阿司匹林丁香酚酯微乳中阿司匹林丁香酚酯及有关物质含量的反相高效液相色谱检测方法

采用反相高效液相色谱法(reversed phase high-performance liquid chromatography,RP-HPLC)测定阿司匹林丁香酚酯微乳(Aspirin eugenol ester microe mulsion,AEE-ME)中阿司匹林丁香酚酯及有关物质的含量。色谱条件为固定相ODS色谱柱(4.6mm×100mm,5μm);流动相甲醇—水(70∶30);流速1.0mL/min;检测波长279nm,柱温30℃。结果表明,阿司匹林丁香酚酯在波长279nm、1.25～40μg/mL范围内浓度与吸收度有良好的线性关系(r=0.9923),平均回收率为99.93%,RSD是0.84%。因此,该方法适用于阿司匹林丁香酚酯及有关物质的含量测定,可用于阿司匹林丁香酚酯的质量控制。

Determination of Content and Related Substances of Aspirin Eugenol Ester Microemulsion by RP-HPLC

To determine the contents of Aspirin eugenol ester microemulsion(AEE-ME) and the related substances in AEE-ME, RP-HPLC method was used. The high performance liquid chromatographic conditions were as followed: ODS column (4.6 mm×100 mm,5 μm) was used as stationary phase and methanol-water (70∶30) was used as mobile phase; the detection wave length was 279 nm; lowing rate was 1.0 mL/min; temperature was 30 ℃. The calibration curves was a good linearity in the range of 1.25 to 40 μg/mL for AEE at 279 nm(r=0.9923),the average recovery rate was 99.93%, and RSD was0.84%. The results showed that the method was suitable for detection of the content and the related substances of Aspirin eugenol ester and could be used in quality control.