Objective To determine the residual substances in viaminate raw materials by high-performance liquid chromatography,identify the structure of unknown impurities,and determine the toxic properties of viaminate and major impurities.Methods Viaminate and major impurities were separated by Agilent Eclipse XDB C18 column(4.6 mm×250 mm,5 μm)with methanol-water(93∶7)as the mobile phase.The detection wavelength was 370 nm and the flow rate was 1.0 mL·min-1.ADMET Predictor software was used to predict the toxicity of viaminate and major impurities.Results Under the selected chromatographic conditions,the peaks of viaminate and impurities were well separated.The methodology met the requirements of analysis and detection.The unknown impurity was an isomer of viaminate according to the mass spectrometry data.The software predicted that viaminate and the major impurities were toxic to the liver.Conclusion The method has simple operation,high accuracy and good reproducibility,and can simultaneously determine the major impurities in viaminate raw materials.Identification of the unknown impurity and toxicity analysis of major impurities provide dada for the quality control of viaminate.
万方数据
维普
