Method for simultaneously determining contents of three impurities in tadalafil
The invention provides a method for simultaneously determining the content of three impurities in tadalafil, and particularly relates to a method for simultaneously qualitatively and quantitatively detecting chloroacetyl chloride, (1R, 3R)-1-(1, 3-benzodioxolane-5-yl)-2-(chloracetyl)-2, 3, 4, 9-tetr...
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Main Authors | , , , , , , , |
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Format | Patent |
Language | Chinese English |
Published |
14.10.2022
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Subjects | |
Online Access | Get full text |
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Summary: | The invention provides a method for simultaneously determining the content of three impurities in tadalafil, and particularly relates to a method for simultaneously qualitatively and quantitatively detecting chloroacetyl chloride, (1R, 3R)-1-(1, 3-benzodioxolane-5-yl)-2-(chloracetyl)-2, 3, 4, 9-tetrahydro-1H-pyridino [3, 4-B] indole-3-carboxylic acid methyl ester and an isomer thereof in tadalafil by adopting high performance liquid chromatography tandem mass spectrometry. The method comprises the following specific steps: adding an acetonitrile solution of an amino compound into a tadalafil test sample for derivatization to prepare a test sample solution; the three impurities are subjected to same derivatization and diluted into standard solutions with different concentrations, and a high performance liquid chromatography-tandem mass spectrometry standard curve is obtained; the test solution is subjected to high performance liquid chromatography tandem mass spectrometry detection to obtain characteristic ion |
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Bibliography: | Application Number: CN202110370335 |