Determination of the Related Substance in Ibuprofen Lysine by RP-HPLC

Chromatographic experiments were performed on Agilent C18 column(15cm×4.6mm×5.0μm),the mobile phase was water(PH 2.5) and acetonitrile(640:360);the detection wavelength was 214 nm,the flow rate was 2.0 ml/min,column temperature was 30 ℃.The results showed that the concentration of sample solution was linear with its peak area in the range of 2.01～40.14ug/ml(equivalent to 0.05%～1.0% ibuprofen sample solution),the correlation coefficients were higher than 0.99,and linear correlation was better;the signal to noise ratio accorded with regulation in the test of the limit of quantification and detection,and may meet the requirement of quantitative detection.The method has strong specificity and reliability,its precision and accuracy fulfilled the requirements,and can be used to the control of the related substance in ibuprofen lysine.