HPLC法测定布洛芬缓释胶囊有关物质

Determination of Ibuprofen Sustained-release Capsules' Related Substances by HPLC

目的:建立高效液相色谱法测定布洛芬缓释胶囊中的有关物质2-(4-丁基苯基)丙酸和4-异丁基苯乙酮。方法:采用十八烷基硅烷键合硅胶为填充剂的色谱柱,流动相为磷酸-乙腈-水(0.5:340:600,待平衡后加水稀释至1000mL),检测波长214nm,进样量为20μL,流速为2.0mL/min。结果:布洛芬缓释胶囊中有关物质2-(4-丁基苯基)丙酸在3.00～9.00μg/mL浓度范围内线性关系良好(γ=0.9992),平均回收率为99.9%,RSD为0.82%。检测限为0.1307μg/mL。4-异丁基苯乙酮在1.19～7.14μg/mL浓度范围内线性关系良好(γ=0.9995),平均回收率为100.2%,RSD为1.00%,检测限为0.1428μg/mL。结论:该方法操作简单、准确,重现性、分离效果好,灵敏度高,能较好的进行布洛芬缓释胶囊中有关物质2-(4-丁基苯基)丙酸和4-异丁基苯乙酮的测定。

Objective：To establish an RP-HPLC method for determination of Ibuprofen Sustained-release Capsules＇ related substances of 2-（4-butylphenyl） -propionic acid,4￠-isobutylacetophenone.Methods：The C18 column was used.The mobile phase was mix 0.5 volumes of phosphoric acid,340 volumes of acetonitrile and 600 volumes of water;allow to equilibrate and dilute to 1000 volumes with water;The detection Spectrophotometer at 214 nm,the flow rate was 2 ml/min.Results：The linear range of Ibuprofen Sustained-release Capsules＇ related substances of 2-（4-butylphenyl） -propionic acid was 3.00 ～9.00μg/ml（γ=0.9992） .The average recovery rate was 99.9%,and RSD=0.82%.Detection limit was 0.1307μg/mL。The linear range of Ibuprofen Sustained-release Capsules＇ related substances of 4￠-isobutylacetophenone was 1.19～7.14μg/mL（γ=0.999 5） .The average recovery rate was 100.2%,and RSD=1.00%.Detection limit was 0.1428μg/mL.Conclusion：The method is simple and accurate with good reproducibility,resolution and sensitivity.It provides a new and reliable means for the quality control to content determination of Ibuprofen Sustained-release Capsules of 2-（4-butylphenyl） -propionic acid and 4￠-isobutylacetophenone.