Determination of process-related impurities and genotoxic impurities in 1-fluoronaphthalene by HPLC
To establish an HPLC method for the detection of two known impurities and one genotoxic impurities contents in 1-fluoronaphthalene.The chromatographic column was Phenomenex Gemini C18 250×4.6 mm,5 μm;the mobile phase was 10 mM sodium bicarbonate+6 mM triethylamine∶acetonitrile=55∶45,isometric elution,and the collection time was twice the retention time of the main peak;the column temperature was 40 ℃;the detection wavelength was 220 nm;the flow rate was 1.0 mL/min;the injection volume was 20 μL.The main component self-comparison with correction factor was used to calculate each impurity,and each impurity could be well separated,the LOQ was 0.005-0.008 μg/ml,and the linear relationship is good,and the precision and accuracy of high,medium and low three concentrations meet the requirements.The results show the method has strong specificity,high sensitivity and easy operation,good repeatability,accurate and reliable results,can be used for impurity control of 1-fluoronaphthalene.
万方数据
维普
