| 引用本文: | 夏佳,陈红娟,席时东.注射用盐酸头孢甲肟的杂质谱研究[J].中国现代应用药学,2023,40(5):654-663. |
| XIA Jia,CHEN Hongjuan,XI Shidong.Impurity Profile Study of Cefmenoxime Hydrochloride for Injection[J].Chin J Mod Appl Pharm(中国现代应用药学),2023,40(5):654-663. |
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| 摘要: |
| 目的 建立UHPLC-TOF-MS法对注射用盐酸头孢甲肟的杂质结构进行研究。方法 采用UHPLC-TOF-MS联用，Waters UPLC HSS T3色谱柱(2.1 mm×100 mm，1.8 μm)，流动相A为0.1%甲酸，流动相B为乙腈，梯度洗脱，柱温40 ℃，流速为0.3 mL·min-1。结果 注射用盐酸头孢甲肟中检出15个有关物质，并对各杂质的结构进行了推测。结论 本实验建立的UHPLC-TOF-MS方法可用于注射用盐酸头孢甲肟的杂质谱研究。 |
| 关键词: 注射用盐酸头孢甲肟 有关物质 杂质谱 飞行时间质谱 |
| DOI：10.13748/j.cnki.issn1007-7693.204690 |
| 分类号:R917.101 |
| 基金项目: |
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| Impurity Profile Study of Cefmenoxime Hydrochloride for Injection |
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XIA Jia1, CHEN Hongjuan2, XI Shidong1
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1.Ningbo Institute for Drug Control, Ningbo 315048, China;2.Nanjing University State Key Laboratory of Pharmaceutical Biotechnology, Nanjing 210046, China
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| Abstract: |
| OBJECTIVE To establish an UHPLC-TOF-MS method for the research of the impurity profile of cefmenoxime hydrochloride for injection. METHODS UHPLC-TOF-MS was used with Waters UPLC HSS T3 column(2.1 mm×100 mm, 1.8 μm). The mobile phase consisted of 0.1% formic acid(A) and acetonitrile(B) with gradient program. The column temperature was 40 ℃. The flow rate was 0.3 mL·min-1. RESULTS There were 15 related substances detected in the sample, all of which were identified. CONCLUSION The UHPLC-TOF-MS method can be used for the related substances study of cefmenoxime hydrochloride for injection. |
| Key words: cefmenoxime hydrochloride for injection related substance impurity profile Tof-MS |
