Analysis method of related substances of dapagliflozin

The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a method for analyzing related substances of dapagliflozin. The method comprises the following steps: carrying out gradient elution by adopting a high performance liquid chromatography, taking a reve...

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Bibliographische Detailangaben
Hauptverfasser: SUN TONG, XIANG YU, WEN SONGSONG, DING BO, WANG WEIJIAN
Format: Patent
Sprache:chi ; eng
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Beschreibung
Zusammenfassung:The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a method for analyzing related substances of dapagliflozin. The method comprises the following steps: carrying out gradient elution by adopting a high performance liquid chromatography, taking a reversed-phase chromatographic column taking high-density octyl modified organic hybrid silica gel as a filling agent and taking a mixed solution of an ammonium acetate buffer solution, methanol and acetonitrile as a mobile phase, and separating the dapagliflozin intermediate and the related substances thereof; and analyzing and detecting by adopting an ultraviolet detector. The invention provides a simple, effective, stable and reliable high performance liquid chromatography analysis method, so that effective separation and determination of the dapagliflozin intermediate and related substances thereof are realized, the quality of the dapagliflozin intermediate is effectively controlled, and the medication safety of da