Simultaneous Determination of 6 Aconitum Alkaloids in Fengshiantai Tablets by UPLC-MS/MS and Risk Assessment
- VernacularTitle:UPLC-MS/MS法同时测定风湿安泰片中6种乌头类生物碱成分含量及风险评价
- Author:
Yuanyuan ZHANG
1
;
Xiaolei WANG
;
Zhenxia ZHAO
;
Yongli LIU
;
Huizhu SUN
;
Jian SU
Author Information
- Keywords: Fengshiantai tablets; UPLC-MS/MS; Alkaloids; Content determination; Chemometrics analysis; Risk assessment
- From: World Science and Technology-Modernization of Traditional Chinese Medicine 2024;26(8):2168-2174
- CountryChina
- Language:Chinese
- Abstract: Objective To establish a UPLC-MS/MS method to measure the content of monoester-alkaloids(benzoylmesaconine,benzoylaconine,benzoylhypaconine)and diester-alkaloids(mesaconitine,hyp-aconitine,aconitine)in Fengshiantai tablets.To provide a basis for quality control by conducting chemometric analysis and risk assessment on the measurement results.Methods The components were separated on Waters BEH C18 column(2.1 mm×100 mm,1.7 μm)with methanol and 0.1%formicacid aqueous solution as the mobile phase by gradient elution at a flow rate of 0.3 mL·min-1.The column temperature was set at 35℃.The injection volume was 1 μL.The detection was carried out by electrospray ionization(ESI),and electron spray ionization source was adopted in positiveion detection with multiple reaction monitoring mode(MRM).Results Six components showed good linear relationships within their own ranges(r≥0.9990),whose average recovery rate of samples were 90.3%-107.6%with the RSD of 0.9%-1.8%.In 23 batches of tested samples,the diester-alkaloids contents ranged from 1.35 to 19.49 μg per tablet,which indicated low risk of drug safety;the monoester-alkaloids contents ranged from 20.17-99.55 μg per tablet.The results of chemometrics showed that 23 batches of samples were classify into four categories,and there were certain differences in sample quality among different production enterprises.Conclusion The established method is stable and reliable,and can be used for quality control of Fengshi Antai tablets.
