Discussion of the Determination of Related Substances in Fluorouracil Injection
OBJECTIVE To establish a reverse phase HPLC for simultaneous determination of six related substances in fluorouracil injection.METHODS Reversed-phase high-performance liquid chromatography(HPLC)was used for the analysis.The chromatographic column used was Hydrophilic C18 column,with a mobile phase of potassium dihydrogen phosphate solution(6.8 g·L-1,using 5 mol·L-1 potassium hydroxide to adjust pH 5.7)and acetonitrile,gradient elution.Aflow rate:1.0 mL·min-1.The detection wavelength was 266 nm,and the column temperature was 35 ℃.The standard curve method and the principal component self-control method(plus correction factor)were used to determine the related substances.RESULTS The relative retention time,correction factor,regression equation and linear range of six related substances were measured respectively.The average relative standard deviation(RSD)of precision and recovery of each control article was below 1.9％,and the average recovery rate was above 95％.By comparing the two calculation results,that the principal component self-control method(plus correction factor)was found to be simpler,more convenient and equally accurate for calculating the content of related substances.The test solution of fluorouracil injection was tested after high temperature,light,oxidation,acid and alkali,fluorouracil was well separated from its degradation product,and could effectively detect the content of each impurity.CONCLUSION This method can be used for the quantitative detection of related substances in fluorouracil injection.Impurities B,D,F(with a correction factor of l.5)and impurity E(with a correction factor of l.3)are calculated by the principal component self-control method(plus correction factor),making it easier to calculate the content of the related substances.
RP-HPLCfluorouracil injectiondetermination of relevant substances
万方数据
维普
