ABSTRACT
Objective To establish a gradient RP￣HPLC method for determining the related substances in lumefantrine. Methods The HPLC analysis was performed on an Agilent nucleosil 100￣5 C18(4.0 mm×125 mm,5 μm) column;the mobile phase was consisted of solution A,B and C,which included phosphate buffer solutions (consisting sodium hexane sulfonate,pH was adjusted to 2. 3 )￣water￣acetonitrile￣propanol with different proportion, with a gradient elution at the flow rate of 2.0 mL.min-1 , the detection wavelength was 265 nm, and the column temperature was 35 ℃ . Results An excellent separation achieved for lumefantrine from its related substances.Lumefantrine had a good linear relationship with the peak area within the range of 0.173 4-0.693 2 μg.mL-1(r= 0.999 6).The limit of determination was 0.06 μg.mL-1 . Conclusion The method is sensitive,reproducible and specific for the separation and determination of related substances in lumefantrine.