摘要
目的分析确定富马酸福莫特罗样品中大于0.1%的有关物质。方法以高效液相色谱法(highperformance liquid chromatography,HPLC)法分析确定的杂质为研究对象,采用液质联用法(LC-MS),确定有关物质。结果分析确定了富马酸福莫特罗样品中存在的一个主要有关物质,该杂质的相对保留时间(Rt=0.7)、分子量和质谱特征均与欧洲药典EP5记载的富马酸福莫特罗中的杂质B相一致。结论本文建立的LC MS方法和实验数据为富马酸福莫特罗的质量控制提供了重要依据。
Objective To analyse related substance in formoterol fumarate sample. Methods Related substances with the amount of more than 0. 1% of formoterol fumarate were determinated by high performance liquid chromatography （HPLC） and high performance liquid chromatography coupled mass spectrometry （LC-MS）. Results One related substance in formoterol fumarate has been determinated. The related substance was identified as impurity B that was recorded in European Pharmacopoeia （Edition 5）. Conclusion The established LC-MS method and results established a basis for quality control and stability study of formoterol fumarate.
出处
《河北医科大学学报》
CAS
2009年第6期585-588,共4页
Journal of Hebei Medical University
关键词
富马酸福莫特罗
色谱法
高压液相
质量控制
formoterol fumarate
chromatography, high pressure liquid
quality control
