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

作　　者：蒋蒨 张熙 李杰 吴华 秦家川 JIANG Qian;ZHANG Xi;LI Jie;WU Hua;QIN Jiachuan(Chongqing Kerui Pharmaceutical(Group)Co.,Ltd.,Chongqing 400060,China)

机构地区：[1]重庆科瑞制药(集团)有限公司,重庆400060

出　　处：《重庆工商大学学报(自然科学版)》2025年第2期26-32,共7页Journal of Chongqing Technology and Business University:Natural Science Edition

基　　金：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);2021年重庆市创新发展项目专项资金(渝国资[2021]305号).

摘　　要：目的建立同时检测卡托普利片中六个已知杂质的方法。方法采用梯度洗脱,色谱柱为WatersμBondapak(300 mm×3.9 mm,10μm);柱温为45℃,流动相为磷酸-水(0.06∶100)(A)和磷酸-水-乙腈(0.06∶50∶50)(B),梯度洗脱(0~5 min,90%A;5~40 min,90%A→60%A;40~55 min,60%A),流速1.5 mL,检测波长:210 nm,进样量:20μL。结果该方法具有良好的专属性,能够有效地分离卡托普利与相邻杂质以及各已知杂质之间的关系。此外,卡托普利和各已知杂质的浓度与峰面积之间呈现良好的线性关系(r>0.9995)。该方法还展示了良好的精密度、准确度和耐用性。自制的卡托普利片与参比制剂在杂质谱上基本一致,并且各批样品均符合质量标准要求。结论该方法具有良好的专属性、准确度、精密度和耐用性,能够有效分离已知的6种杂质,是一种合理可靠的卡托普利片质量控制方法。Objective A method was developed for the simultaneous detection of six known impurities in captopril tablets.Methods Gradient elution was employed,with WatersμBondapak column(300 mm×3.9 mm,10μm)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 20μL.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>0.9995).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 

分 类 号：TQ460.72[医药卫生—药物分析学]