HPLC法测定布洛芬注射液中4-异丁基乙酰苯

Determination of 4-Isobutylacetophenone in Ibuprofen Injections by HPLC

目的:建立布洛芬注射液中有关物质4-异丁基乙酰苯的HPLC测定法。方法:采用Phenomenix Luna C_(18)(150 mm×4.6 mm,5μm)色谱柱,以0.1%的磷酸溶液-乙腈(200:800)为流动相,流速为1.0 ml·min^(-1),检测波长为254 nm,柱温为室温。结果:4-异丁基乙酰苯在0.23～23.00 ng范围内线性关系良好,r=1.000 0,平均回收率为99.7%,RSD为1.6%(n=9);4-异丁基乙酰苯检测限为0.06 ng。结论:该方法准确可靠,专属性强,可用于布洛芬注射液中的4-异丁基乙酰苯含量测定。

Objective：To establish a method for the detection of 4-isobutylacetophenone in ibuprofen injections by HPLC.Method： A Phenomenix Luna C_（18）（150 mm×4.6 mm,5μm） column was used,the mobile phase consisted of 0.1%phosphoric solution acid and acetonitrile（200：800）,the flow rate was 1.0 ml ？ min^（-1） and the detection wavelength was at 254 nm.Result：The linear range was 0.23-23.00 ng for 4-isobutylacetophenone（r = 1.000 0）.The average recovery was 99.7%with RSD of 1.6%（n = 9 ）. The detective limit was 0.06 ng.Conclusion：The method is accurate,reliable and specific,which can be used for the determination of 4-isobutylacetophenone in ibuprofen injections.