文章摘要
王红,崔永伟.HPLC-ESI-MS/MS法同时测定血必净注射液中 11种有效成分的含量[J].药学与临床研究,2021,29(4):246~250
HPLC-ESI-MS/MS法同时测定血必净注射液中 11种有效成分的含量
Determination of 11 Active Constituents in Xuebijing Injections by HPLC-ESI-MS/MS
投稿时间:2020-11-11  修订日期:2021-08-13
DOI:
中文关键词: 血必净  化学成分  HPLC-ESI-MS/MS法
英文关键词: Xuebijing injection  Components  HPLC-ESI-MS/MS
基金项目:南京药学会-常州四药医院药学科研基金项目(2017YX013);南京市中医药青年人才培养计划项目(ZYQ20059)
作者单位E-mail
王红 南京市溧水区中医院 wanghong198942@126.com 
崔永伟 南京市溧水区中医院 njcyongw@126.com 
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中文摘要:
      目的:建立HPLC-ESI-MS/MS法同时测定血必净注射液中11种指标性成分的含量。方法:采用Agilent Extend-C18柱(2.1 mm × 100 mm,1.8 μm),流动相为0.1%甲酸水-乙腈,梯度洗脱,流速为0.3 mL·min-1;质谱采用ESI正、负离子同时采集,多反应监测(MRM)模式扫描,测定含量。结果:在优化的色谱质谱条件下,11种成分分别在5.000~500.0、1.000~800.0、40.00~8000、4.000~800.0、10.00~8000、0.6250~500.0、0.5000~100.0、1.000~800.0、10.00~500.0、2.000~800.0、1.000~800.0 ng·mL-1线性关系良好(r2≥0.9961),平均加样回收率97.01%~102.70%(RSD≤6.4%);测定结果表明,11种成分在6个批次血必净注射液中含量较为稳定。结论:该方法简便、灵敏、高效,可用于血必净注射液中多种成分的快速测定,为其质量控制研究提供科学的依据。
英文摘要:
      Objective: To establish an HPLC-ESI-MS/MS method for simultaneous determination of 11 active or potential sensitizing components in Xuebijing injections. Methods: The chromatographic separation was achieved on an Agilent Extend-C18 (2.1 mm × 100 mm, 1.8 μm) column; The mobile phase was consisted of 0.1% formic acid water-acetonitrile at a flow rate of 0.3 mL·min-1 with gradient elution, the mass spectrums were scanned by ESI+ and ESI- multiple reaction monitoring (MRM) mode. Results: Under the optimized conditions, the 11 components showed good linear relationships in the ranges of 5.000-500.0, 1.000-800.0, 40.00-8000, 4.000-800.0, 10.00-8000, 0.6250-500.0, 0.5000-100.0, 1.000-800.0, 10.00-500.0, 2.000-800.0 or 1.000~800.0 ng·mL-1, respectively (r2≥0.996 1), whose average recoveries were 97.01%-102.70% (RSD≤6.4%). The analysis results showed that the quantities of the 11 components were stable in six batches of Xuebijing injections. Conclusion: This simple, sensitive, and efficient method can be used for the rapid determination of multiple index components, which provide a scientific basis for the quality control research of Xuebijing injections.
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