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Determination and limit of aflatoxins in Hongyao tablets

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Author:
No author available
Journal Title:
Central South Pharmacy
Issue:
8
DOI:
10.7539/j.issn.1672-2981.2024.08.034
Key Word:
红药片;黄曲霉毒素;高效液相色谱-质谱联用法;TD50;Hongyao tablet;aflatoxin;HPLC-MS;TD 50

Abstract: Objective To establish a liquid chromatography-mass spectrometry(HPLC-MS)method for the determination of aflatoxins(aflatoxins B1,aflatoxins B2,aflatoxins G1 and aflatoxins G2)in Hongyao tablets,and to set limits on the amount of aflatoxins in Hongyao tablets.Methods The chromatographic column was Venusil MP C18(4.6 mm× 150 mm,5 μm).The mobile phase consisted of 2 mmol·L-1 ammonium acetate solution(A)-methanol(B)with gradient mode.Electrospray ionization source(ESI)was used for the determination by tandem mass spectrometer,and the positive ion mode was adopted.Results The linear calibration curves were obtained at 0.0108~54.0 ng·mL-1 for aflatoxins B1,0.0145~14.5 ng·mL-1 for aflatoxins B2,0.0101~50.5 ng·mL-1 for aflatoxins G1,and 0.0150~15.0 ng·mL-1 for aflatoxins G2,respectively.The recoveries of aflatoxins B1,B2,G1 and G2 were 89.24%,80.31%,87.06%and 74.19%,respectively.The RSDs of repeatability were 2.9%,4.6%,3.3%and 5.0%,respectively.The content and total amount of aflatoxins B1,B2,G1 and G2 in 6 batches of Hongyao tablets were all lower than the aflatoxins limits.Conclusion The HPLC-MS method is established for the determination of aflatoxins in Hongyao tablets,and the limit of aflatoxins in Hongyao tablets is established at the same time,which provids a new idea and theoretical reference for the determination of aflatoxins content in other proprietary Chinese medicines.

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