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Content determination and quality evaluation of 18 components in Fengshiantai tablets based on UPLC-MS/MS technology and chemometrics*
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Yuan-yuan ZHANG, Hui-zhu SUN, Xiao-lei WANG, Rong LEI, Xue-li LIU, Jian SU**
Chinese Journal of Pharmaceutical Analysis | 2024, 44(10) : 1816 - 1826
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(10): 1816-1826
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Content determination and quality evaluation of 18 components in Fengshiantai tablets based on UPLC-MS/MS technology and chemometrics*
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Yuan-yuan ZHANG, Hui-zhu SUN, Xiao-lei WANG, Rong LEI, Xue-li LIU, Jian SU**
Affiliations
  • Hebei Institute for Drug and Medical Device Control, Shijiazhuang 050227, China
Published: 2024-10-31 doi: 10.16155/j.0254-1793.2024-0076
Outline
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Objective:

To establish an UPLC-MS/MS method to measure the content of 18 characteristic components in Fengshiantai tablets,and conduct chemometric analysis on the measurement results to provide a basis for quality control.

Methods:

The components were separated on Waters BEH C18 (100 mm×2.1 mm,1.7 μm) column with methanol and 0.1% formic acid aqueous solution as the mobile phase by gradient elution at a flow rate of 0.2 mL·min-1. The column temperature was set at 40 ℃. The injection volume was 1 μL. The detection was carried out by electrospray ionization(ESI),and electron spray ionization source was adopted in positive ion detection with multiple reaction monitoring mode(MRM).

Results:

The established methods showed a good linear relationship in a certain range (r≥0.998 3),whose average recovery rates of samples were 90.2%-101.7% with the RSD of 1.1%-4.9%. The content of ephedrine(calculated as ephedrine hydrochloride),chlorogenic acid,syringin,strychnine,brucine,berberine(calculated as berberine hydrochloride),naringin,cinnamaldehyde,ginsenoside Re,ginsenoside Rg1,epimedin C,icariin,asperosaponin Ⅵ,glycyrrhizic acid(calculated as glycyrrhizic acid ammonium salt),ginsenoside Rb1,notopterol,isoimperatorin in 39 batches of samples were 20.23-141.75 μg per tablet,10.50-121.69 μg per tablet,215.24-697.34 μg per tablet,8.46-42.42 μg per tablet,135.24-363.32 μg per tablet,91.29-242.87 μg per tablet,19.65-80.31 μg per tablet,22.57-105.05 μg per tablet,4.69-86.88 μg per tablet,10.32-241.15 μg per tablet,3.36-65.07 μg per tablet,10.79-390.69 μg per tablet,6.51-86.29 μg per tablet,4.10-89.75 μg per tablet,195.55-566.37 μg per tablet,96.98-448.95 μg per tablet,0-132.41 μg per tablet,7.09-232.71 μg per tablet. The results of chemometrics showed that 39 batches of samples from 5 production enterprises were classify into three categories,and there were certain differeces in sample quality among different production enterprises,eight differential markers(naringin,glycyrrhizic acid,isoimperatorin,berberine,syringin,ephedrine,pseudoephedrine,strychnine) that caused quality differences were found.

Conclusion:

The established method is simple and feasible,combined with chemometric methods,and can be used for quality evaluation of Fengshiantai tablets.

Fengshiantai tablets  /  UPLC-MS/MS  /  characteristic components  /  content determination  /  chemometrics  /  risk assessment  /  quality evaluation
Yuan-yuan ZHANG, Hui-zhu SUN, Xiao-lei WANG, Rong LEI, Xue-li LIU, Jian SU. Content determination and quality evaluation of 18 components in Fengshiantai tablets based on UPLC-MS/MS technology and chemometrics*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (10) : 1816 -1826 . DOI: 10.16155/j.0254-1793.2024-0076
Year 2024 volume 44 Issue 10
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doi: 10.16155/j.0254-1793.2024-0076
  • Receive Date:2024-02-02
  • Online Date:2026-03-15
  • Published:2024-10-31
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  • Received:2024-02-02
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    Hebei Institute for Drug and Medical Device Control, Shijiazhuang 050227, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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