Objective To determine the related substances and impurity profile in vinpocetine injection,and to identify the relationship between the sources of impurities and the production.Methods The separation was performed on an ACE Excel C18(4.6 mm × 250 mm,5 pm)column with gradient elution with the mobile phase consisting of acetonitrile-0.2 mol·L-1 ammonium acetate solution.The flow rate was 1.0 mL·min-1,the detection wavelength was 280 nm,and the column temperature was 35 ℃.The related substances in 79 batches of vinpocetine injection from 7 enterprises were determined.The structure of the biggest unknown impurity was estimated by UHPLC-Q-TOF,and the impurities were identified and attributed to the source of the impurities by combining the damage test,process analysis and simulated sterilization process.Results The optimized detection method effectively separated and determined 8 known impurities in vinpocetine,including impurity A,B,C,D,F,vincamine,benzaldehyde and furfural.Finally 3～6 known impurities and 1～3 unknown impurities were detected in the 7 enterprises.Impurity A was the biggest known impurity,and the median result of each manufacturer was 0.22％～0.31％.The biggest unknown impurity showed similar structure with vinpocetine with the median of each manufacturer at 0.034％～0.082％;and the median of total impurity at 0.53％～0.73％.The impurity spectrum varied with manufacturers.Conclusion The proposed chromatographic method can be used for the analysis of related substances and quality control of the injection.Furfural and benzaldehyde are impurities introduced by the degradation of excipients.Impurity A,B,C,D,F and vincamine are impurities from the process,and impurities A and F are also degradation impurities.
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