| 引用本文: | 周向荣,李硕,汤林熹,赖振洪,康圆,曾环想,钟佳胜.注射用盐酸头孢吡肟降解杂质研究[J].中国现代应用药学,2025,42(14):45-52. |
| ZHOU XIANGRONG,LI SHUO,TANG LINXI,LAN ZHENHONG,KANG YUAN,ZENG HUANXIANG,ZHONG JIASHENG.Analysis of Degradation Impurities in Cefepime Hydrochloride for Injection[J].Chin J Mod Appl Pharm(中国现代应用药学),2025,42(14):45-52. |
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| 摘要: |
| 目的 建立高效液相色谱-四级杆-飞行时间质谱(HPLC-Q-TOF/MS)方法，对注射用盐酸头孢吡肟的降解杂质谱进行系统分析。方法 采用Inertsil ODS-3(4.6 mm × 250 mm, 5 μm)色谱柱，以0.1%甲酸-水溶液(用氨水调节pH值至5.0)和乙腈为流动相梯度洗脱，流速为1.0 mL·min-1。采用电喷雾离子源ESI,正离子检测模式，通过一级和二级质谱信息对杂质进行结构解析。结果 所建立的分析方法可有效分离注射用盐酸头孢吡肟的降解杂质，通过Q-TOF/MS鉴定出8个主要降解产物的结构，推测了头孢吡肟的降解途径。结论 本方法可用于注射用盐酸头孢吡肟的杂质研究，同时，研究结果为注射用盐酸头孢吡肟的生产运输贮藏、全面质量控制和临床应用提供了参考。 |
| 关键词: 头孢吡肟 HPLC-Q-TOF/MS 降解杂质 |
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| Analysis of Degradation Impurities in Cefepime Hydrochloride for Injection |
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ZHOU XIANGRONG, LI SHUO, TANG LINXI, LAN ZHENHONG, KANG YUAN, ZENG HUANXIANG, ZHONG JIASHENG
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国药集团致君（深圳）制药有限公司
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| Abstract: |
| OBJECTIVE To establish a HPLC-Q-TOF/MS method for the analysis of degradation impurities in cefepime hydrochloride for injection. METHODS Chromatographic separation was performed on an Inertsil ODS-3 column (4.6 mm × 250 mm, 5 μm) with 0.1% formic acid-water solution (adjust pH to 5.0 with ammonia solution) and acetonitrile as mobile phase by gradient elution at a flow rate of 1.0 mL?min-1. The structure of impurities was identified by MS and MS/MS information obtained using an electrospray ionization (ESI) source in positive ion mode. RESULTS The established method can effectively separate impurities in cefepime hydrochloride for injection. Eight major degradation impurities in drug were identified, and degradation pathways of cefepime was proposed. CONCLUSION The HPLC-Q-TOF/MS method can be used to analyze impurities in cefepime hydrochloride for injection, and the results can provide reference for manufacture, transport, storage, quality control and clinical use of cefepime hydrochloride for injection. |
| Key words: cefepime HPLC-Q-TOF/MS degradation impurities |
