HPLC法测定小儿布洛芬口服溶液中布洛芬的含量

Content determination of Ibuprofen in Paediatric Ibuprofen Oral Solution by HPLC

目的:建立高效液相法测定小儿布洛芬口服溶液中布洛芬含量的方法。方法:采用CenturySIL ODS2(4.6mm×200mm,5μm)色谱柱;流动相:醋酸钠缓冲液(取醋酸钠6.13g,加水750ml,振摇使溶解,用冰醋酸调节pH值至2.5)-乙腈(40:60);检测波长:265nm;流速:1.0ml/min;柱温:30℃。结果:布洛芬在0.2～1.4mg/ml范围内与峰面积呈良好的线性关系(r=0.9999),平均回收率为98.1%,RSD=1.2%(n=9)。结论:本法简便、准确、重现性好,可用于小儿布洛芬口服溶液中布洛芬的质量控制。

Objective：To establish a method for the content determination of Ibuprofen in Paediatric Ibuprofen Oral Solution by HPLC.Methods：The CenturySIL ODS2（4.6 mm×200 mm,5 μm） column was used.The mobile phases consisted of sodium acetate buffer solutions（Weighed sodium acetate 6.13 g,added water 750 ml,shake for dissolution,adjusted with glacial acetic acid to a pH of 2.5） and acetonitrile（40：60）,the flow rate was 1.0 ml/min and the detection wavelength was at 265 nm,the column temperature was 30℃.Results：The linear ranges of Ibuprofen was at 0.2～1.4 mg/ml（r=0.999 9）,the average recovery was 98.1% with a RSD of 1.2%（n=9）.Conclusion：The method is fast,reliable,accurate and can be used in the quality control of Ibuprofen in Paediatric Ibuprofen Oral Solution.