重庆工商大学学报（自然科学版）2025，Vol.42Issue(2)：26-32,7.DOI:10.16055/j.issn.1672-058X.2025.0002.004
高效液相色谱法测定卡托普利片中的6个杂质
Determination of Six Impurities in Captopril Tablets by High-performance Liquid Chromatography
摘要
Abstract
Objective A method was developed for the simultaneous detection of six known impurities in captopril tablets.Methods Gradient elution was employed,with Waters μ Bondapak® column(300 mm×3.9 mm,10 μm)used as the chromatographic column;column temperature was set at 45 ℃,and the mobile phase consisted of phosphoric acid-water(0.06∶100)(A)and phosphoric acid-water-acetonitrile(0.06∶50∶50)(B),with gradient elution(0～5 min,90％A;5～40 min,90％A→60％A;40～55 min,60％A),flow rate of 1.5 mL,detection wavelength of 210 nm,and injection volume of 20 μL.Results The method demonstrated good specificity,effectively separating captopril from adjacent impurities and known impurities.Moreover,captopril and the known impurities showed a good linear relationship between concentration and peak area(r＞0.999 5).The method also exhibited good precision,accuracy,and durability.The impurity profiles of the self-made captopril tablets and the reference formulation were basically consistent,and all batches of samples met the quality standard requirements.Conclusion The method possesses good specificity,accuracy,precision,and durability,and can effectively separate the six known impurities,making it a reasonable and reliable method for quality control of captopril tablets.关键词
卡托普利片/杂质/质量控制/高效液相色谱法Key words
captopril tablets/impurities/quality control/high-performance liquid chromatography分类
化学工程引用本文复制引用
蒋蒨,张熙,李杰,吴华,秦家川..高效液相色谱法测定卡托普利片中的6个杂质[J].重庆工商大学学报（自然科学版）,2025,42(2):26-32,7.基金项目
2018年第二批重庆市工业和信息化专项资金项目(渝经信产业[2018]54号、渝财产业[2018]209号) （渝经信产业[2018]54号、渝财产业[2018]209号）
2021年重庆市创新发展项目专项资金(渝国资[2021]305号). （渝国资[2021]305号）
