| 引用本文: | 夏佳,席时东.UPLC测定盐酸头孢甲肟原料药及注射剂的有关物质[J].中国现代应用药学,2019,36(22):2769-2772. |
| XIA Jia,XI Shidong.Determination of Related Substances of Cefmenoxime Hydrochloride Drug Substance and Injection by UPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2019,36(22):2769-2772. |
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| 摘要: |
| 目的 建立UPLC测定盐酸头孢甲肟原料药及注射剂中有关物质的方法。方法 采用Zorbax XDB C18柱（2.1 mm×100 mm，3 μm），流动相A为水-冰醋酸-乙腈（85∶1.7∶15），流动相B为水-冰醋酸-乙腈（50∶1.7∶50），梯度洗脱，柱温30℃，流速为0.6 mL·min-1，检测波长为254 nm。结果 盐酸头孢甲肟与中间体、副产物完全分离。有关物质重复性RSD为2.5%，检测限为0.001~0.08 μg·mL-1。结论 该方法快速、简便、灵敏度高、重复性好，优于现行标准方法。 |
| 关键词: 超高效液相色谱法 盐酸头孢甲肟 有关物质 |
| DOI：10.13748/j.cnki.issn1007-7693.2019.22.004 |
| 分类号:R927.11 |
| 基金项目:2018年国家药品抽样评价 |
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| Determination of Related Substances of Cefmenoxime Hydrochloride Drug Substance and Injection by UPLC |
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XIA Jia, XI Shidong
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Ningbo Institute for Drug Control, Ningbo 315048, China
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| Abstract: |
| OBJECTIVE To establish UPLC for the determination of related substances of cefmenoxime hydrochloride drug substance and injection. METHODS The column was Zorbax XDB C18(2.1 mm×100 mm, 3μm). The mobile phase consisted of water-acetic acid-acetonitrile(85:1.7:15)(A) and water-acetic acid-acetonitrile(50:1.7:50)(B) with gradient program. The column temperature was 30℃. The flow rate was 0.6 mL·min-1 and the detection wavelength was 254 nm. RESULTS Cefmenoxime hydrochloride could be completely separated from its intermediates and by-products. The RSD of related substances precision was 2.5%, the detection limit was 0.001-0.08 μg·mL-1. CONCLUTION The method is rapid, simple, sensitive, reproducible and better than the current standard method. |
| Key words: UPLC cefmenoxime hydrochloride related substances |
