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超高效液相色谱法在药物有关物质分析中的应用

邬伟魁,严倩茹   

  1. 梅州市食品药品监督检验所,梅州市食品药品监督检验所
  • 收稿日期:2015-08-14 修回日期:2015-10-13 出版日期:2015-10-25 发布日期:2015-10-25

Application of ultra high performance liquid chromatography in the analysis of related substances in drugs

  1. Meizhou Institute for Food and Drug Control,Meizhou Institute for Food and Drug Control
  • Received:2015-08-14 Revised:2015-10-13 Online:2015-10-25 Published:2015-10-25

摘要: 药物有关物质的控制是药品安全、有效的重要保障,是评价药品质量优劣的关键指标。近年来,超高效液相色谱法在药物有关物质分析领域的应用逐渐增多,如:测定原料药、制剂的有关物质,同时测定药物的含量和有关物质等。

Abstract: The control of drug related substances is an important guarantee for drug safety and effective. In recent years, application of ultraShigh performance liquidSchromatographySin theSanalysis ofSrelated substances in drugs gradually increased, such as: determination of related substances in the raw material medicine and preparation, simultaneous determination of drug content and related substances.