中国临床药理学杂志2025，Vol.41Issue(5)：712-716,5.DOI:10.13699/j.cnki.1001-6821.2025.05.022
用HPLC-MS/MS法测定人血浆中尼可地尔浓度
Concentration of nicorandil in human plasma was determined by HPLC-MS/MS
陈朝丽 1闫宇航 1周春华 2王建欣 1杨兰 1张娜娜 1史凌雪 1段立广 1安绯悦 1伦杨 1王佳琪1
作者信息
- 1. 河北医科大学第一医院临床药学部,河北石家庄 050000
- 2. 河北医科大学第一医院临床药学部,河北石家庄 050000||河北省人工智能临床药学技术创新中心,河北石家庄 050000
- 折叠
摘要
Abstract
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.关键词
尼可地尔/高效液相色谱-质谱法/血药浓度/药代动力学Key words
nicorandil/high performance liquid chromatography-mass spectrometry/blood concentration/pharmaco-kinetics分类
医药卫生引用本文复制引用
陈朝丽,闫宇航,周春华,王建欣,杨兰,张娜娜,史凌雪,段立广,安绯悦,伦杨,王佳琪..用HPLC-MS/MS法测定人血浆中尼可地尔浓度[J].中国临床药理学杂志,2025,41(5):712-716,5.
