中国药物评价2018，Vol.35Issue(6)：409-413,5.
LC-MS法检测国产盐酸贝那普利片中有关物质的研究
Determination of Related Substances in Benazepril Hydrochloride Tablets by LC-MS
梁爱仙 1庞发根 1陈承贵 1蔡锦雄 1李玉兰1
作者信息
- 1. 深圳市药品检验研究院,深圳药品质量标准研究重点实验室,广东 深圳 518057
- 折叠
摘要
Abstract
Objective:To develop a liquid chromatograph-mass spectrometer (LC-MS) method for the determination of related substances in Benazepril hydrochloride tablets.Methods:The separation was performed on a Waters Sun Fire C18column (2.1 mm×150 mm, 5μm) at a flow rate of 0.2 m L·min-1and an injection volume of 20μL, by a gradient elution using 0.1 mol·L-1ammonium acetate solution (acetic acid adjusted p H to 3.0) as mobile phase A and methanol as mobile phase B.The detection wavelength was set at 240nm.The column temperature was 35℃.MS scan range was 100-1 000 amu.Results:The proposed method was used to detect the related substances in Benazepril hydrochloride tablets from different pharmaceutical manufactures.The chemical structures of related substances were analyzed by LC-MS.Conclusion:The developed method is appropriate for determination of related substances in Benazepril hydrochloride tablets.关键词
盐酸贝那普利/有关物质/高效液相色谱-质谱Key words
Benazepril hydrochloride/Related substance/Liquid chromatograph-mass spectrometer (LC-MS) 分类
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梁爱仙,庞发根,陈承贵,蔡锦雄,李玉兰..LC-MS法检测国产盐酸贝那普利片中有关物质的研究[J].中国药物评价,2018,35(6):409-413,5.
