| 引用本文: | 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/M/D/N,J:杂志，M：书，D：论文，N：报纸).期刊名称,2025，42（2）：26-32 |
| CHEN X. Adap tive slidingmode contr ol for discrete2ti me multi2inputmulti2 out put systems[ J ]. Aut omatica, 2006, 42(6): 4272-435 |
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| 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 Waters μ Bondapak?
(300 mm×3. 9 mm,10 μm) ;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:20 μL。 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. 999 5) 。 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。 |
| 关键词: 卡托普利片 杂质 质量控制 高效液相色谱法 |
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| Determination of Six Impurities in Captopril Tablets by High-performance Liquid Chromatography |
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IANG Qian ZHANG Xi LI Jie WU Hua QIN Jiachuan
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Chongqing Kerui Pharmaceutical Group Co. Ltd. Chongqing 400060 China
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| Abstract: |
| 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. |
| Key words: captopril tablets impurities quality control high-performance liquid chromatography |
