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Concentration of nicorandil in human plasma was determined by HPLC-MS/MS
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Chao-li CHEN1, Jian-xin WANG1, Lan YANG1, Na-na ZHANG1, Ling-xue SHI1, Li-guang DUAN1, Fei-yue AN1, Yang LUN1, Jia-qi WANG1, Yu-hang YAN1, Chun-hua ZHOU1, 2
Chinese Journal of Clinical Pharmacology | 2025, 41(5) : 712 - 716
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Chinese Journal of Clinical Pharmacology | 2025, 41(5): 712-716
Research Method
Concentration of nicorandil in human plasma was determined by HPLC-MS/MS
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Chao-li CHEN1, Jian-xin WANG1, Lan YANG1, Na-na ZHANG1, Ling-xue SHI1, Li-guang DUAN1, Fei-yue AN1, Yang LUN1, Jia-qi WANG1, Yu-hang YAN1, Chun-hua ZHOU1, 2
Affiliations
  • 1.Department of Clinical Pharmacy, The First Hospital of Hebei Medical University, Shijiazhuang 050000, Hebei Province, China
  • 2.The Technology Innovation Center for Artificial Intelligence in Clinical Pharmacy of Hebei Province, Shijiazhuang 050000, Hebei Province, China
Published: 2025-03-17 doi: 10.13699/j.cnki.1001-6821.2025.05.022
Outline
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Objective

To establish a high performance liquid chromatography-mass spectrometry (HPLC-MS/MS) method for the determination of nicorandil concentrations in human plasma and for pharmacokinetic studies in healthy subjects.

Methods

Human plasma samples were pretreated with acetonitrile extraction. Chromatographic cdumn: Acquity HPLC BEH C18 (1.7 μm, 2.1 mm×50.0 mm), mobile phase: methanol (0.1% formic acid)-5 mmoL· L-1 ammonium acetate (with 0.1% formic acid). Flow rate: 0.2 mL·min-1, column temperature: 40 ℃, injection volume: 5 μL. Gradient elution, electrospray ion source, multiple reaction monitoring, positive ion scanning, nicorandil-d4 isotope as internal standard. The specificity of the method, the standard curve and the lower limit of quantification, the carryover effect and dilution reliability, the precision and recovery, the matrix effect, and the stability of the method were investigated.

Results

The specificity of the established method was good, nicorandil had a good linear relationship between 0.2-200.0 ng·mL-1, the standard curve was y=1.08×10-1x+2.66×10-2 (r=0.999 7), the lower limit of quantification was 0.2 ng·mL-1, there was no residual effect, the dilution results were reliable, and the intra-day and inter-day precision of quality control samples were 0.64%-8.70% and 0.91%-8.70%, respectively. The intra-day and inter-day accuracy were 100.00%-115.00% and 98.00%-115.00%, respectively. The extraction recoveries of nicorandil at low, medium and high quality control concentrations were 92.78%-95.35%, with no obvious matrix effect and good stability.

Conclusion

This method is highly specific, accurate, stable, reproducible, and simple to operate, and can be used to determine the concentration of drug in plasma of nicorandil.

nicorandil  /  high performance liquid chromatography-mass spectrometry  /  blood concentration  /  pharmacokinetics
Chao-li CHEN, Jian-xin WANG, Lan YANG, Na-na ZHANG, Ling-xue SHI, Li-guang DUAN, Fei-yue AN, Yang LUN, Jia-qi WANG, Yu-hang YAN, Chun-hua ZHOU. Concentration of nicorandil in human plasma was determined by HPLC-MS/MS[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (5) : 712 -716 . DOI: 10.13699/j.cnki.1001-6821.2025.05.022
Year 2025 volume 41 Issue 5
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Article Info
doi: 10.13699/j.cnki.1001-6821.2025.05.022
  • Receive Date:2024-09-27
  • Online Date:2026-08-04
  • Published:2025-03-17
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History
  • Received:2024-09-27
Affiliations
    1.Department of Clinical Pharmacy, The First Hospital of Hebei Medical University, Shijiazhuang 050000, Hebei Province, China
    2.The Technology Innovation Center for Artificial Intelligence in Clinical Pharmacy of Hebei Province, Shijiazhuang 050000, Hebei Province, 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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