Method for detecting benzyl oxidized-O-OH impurities in empagliflozin tablet

The invention provides a method for detecting a benzyl oxidized-O-OH impurity in an empagliflozin tablet. According to the detection method, a high performance liquid chromatography-mass spectrometry combined method is adopted for detection, the structure of the benzyl oxidized-O-OH impurity is show...

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Hauptverfasser: WANG WEISHI, WANG GANG, WANG KUN, SUN XIAOYUAN, WANG YANMIN, MA YUANZHAN
Format: Patent
Sprache:chi ; eng
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Beschreibung
Zusammenfassung:The invention provides a method for detecting a benzyl oxidized-O-OH impurity in an empagliflozin tablet. According to the detection method, a high performance liquid chromatography-mass spectrometry combined method is adopted for detection, the structure of the benzyl oxidized-O-OH impurity is shown as a formula I: # imgabs0 #, and the detection conditions of high performance liquid chromatography comprise that a T3 chromatographic column is adopted, an ammonium acetate solution is used as a mobile phase A, acetonitrile is used as a mobile phase B, the volume percent of the mobile phase A to the mobile phase B is 55-70%: 30-45%, the volume percent of the T3 chromatographic column is 30-70%, the volume percent of the T3 chromatographic column is 30-40%, and the volume percent of the T3 chromatographic column is 30-40%. Isocratic elution is adopted; the detection conditions of the mass spectrum comprise that an ESI ion source is adopted, and quantitative analysis is carried out in a positive ion mode in a mult