目的:建立梯度洗脱HPLC法测定布洛芬的有关物质。方法:色谱柱为Intersil ODS-3(250 mm×4.6 mm,5μm),以0.75%。磷酸水溶液为流动相A,以乙腈为流动相B,梯度洗脱,流速为2.0 ml·min~(-1);检测波长214 nm,柱温40℃。结果:布洛芬杂质B在1.2～10.8μg·ml~(-1)的范围内,与峰面积呈良好的线性关系(r=0.999 9)。结论:本方法简便、灵敏、专属,重复性好,结果准确可靠,可用于测定布洛芬的有关物质。 Objective: To establish a gradient elution HPLC method for the determination of related substances in ibuprofen. Method: The column was Intersil ODS-3 (250 mm × 4.6 mm, 5 μm) at 0.75%. The aqueous solution of phosphoric acid was mobile phase A, acetonitrile was used as mobile phase B and the gradient elution was performed at a flow rate of 2.0 ml · min -1. The detection wavelength was 214 nm and the column temperature was 40 ℃. Results: The impurity B of ibuprofen was in the range of 1.2-10.8 μg · ml -1 and had a good linear relationship with the peak area (r = 0.999 9). Conclusion: The method is simple, sensitive, specific, reproducible, accurate and reliable, and can be used to determine the related substances of ibuprofen.