A high performance liquid chromatographic(HPLC) method was developed for the determination of tranexamic acid(TA) in toothpaste.Sample was extracted with methanol, and the extract was evaporated to dryness under nitrogen before it was derived with dansyl chloride.Chromatographic separation was performed on an X-Bridge C18(250 mm×4.6 mm×5 μm) column using 0.1% formic acid-acetonitrile mixture aqueous solution as mobile phase.The ultraviolet detection wavelength was set at 250 nm.Effects of pH value of buffer solution,reaction temperature and time were investigated.Under the optimized experimental conditions,the TA derivative was successfully separated from the other impurities, and showed a good linearity in the range of 1-425 mg/L with a correlation coefficient(r) of 0.999 5.At three spiked concentrations of 20,200,1 600 mg/kg,the recoveries ranged from 98.7% to 102% with relative standard deviations(RSDs) of 0.85%-2.5%.The limit of detection for this method was 2.0 mg/kg.With the advantages of accuracy,reliability and high sensitivity,this method was suitable for the determination of tranexamic acid in different kinds of toothpaste.
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Shenzhen Institue for Drug Control,NMPA Key Laboratory for Monitoring and Evaluation of Cosmetics