Determination of ten kinds of biogenic amines in sojae semen praeparatum by HPLC
Objective To develop a method for the determination of ten kinds of biogenic amines in sojae semen praeparatum(SSP)by HPLC with precolumn derivatization,and to provide data for evaluating the safety status of SSP.Methods The properties and con-tents(daidzein and genistein)of SSP were detected according to the provisions of Chinese Pharmacopoeia 2020 edition from June to Oc-tober 2023.The content of biogenic amines in SSP conforming to pharmacopoeia regulations was determined by HPLC.The separation was achieved using a Agilent C18 analytical column(4.6mm×250 mm,5 μm).Using ACN and ultra-pure water as the mobile phase solu-tion,a gradient elution was conducted at a flow rate of 0.8 mL/min.The detector was adjusted to 254 nm,with a column temperature of 35℃.Results Three samples did not meet the requirements of Chinese Pharmacopoeia 2020 edition.Tyramine,cadaverine,and pu-trescine were detected in 17 samples that comply with pharmacopoeia regulations,but dopamine was not detected.The total content of biogenic amines varies greatly among different batches,ranging from 27.688 to 8 936.9 μg/g.The content range of tryptamine,2-phenethylamine,putrescine,cadaverine,histamine,5-hydroxytryptamine,tyramine,spermidine and spermine was 0-343.6,0-1 067,12.42-1 819,2.278-4 812,0-320.3,0-11.94,4.936-2 684,0-185.9,and 0-28.64 μg/g.Conclusion The content of histamine,tyra-mine,and 2-phenylethylamine in some SSP that meet the requirements of Chinese Pharmacopoeia 2020 edition exceeds the maximum recommended limit,and the total content of biogenic amines in 6 batches(35%)of SSP exceeded research recommendations,posing a certain safety risk.
万方数据
维普
