Method for detecting azacitidine impurities

The invention relates to a method for detecting azacitidine impurities, and belongs to the technical field of azacitidine quality control. The invention provides a method for detecting azacitidine impurities, which adopts liquid chromatography, a stationary phase is unterminated octadecylsilane chem...

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Hauptverfasser: FAN XING, HU HEPING, WU ZHUOXUE, NIU PO, XU MIN, ZHANG LI
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention relates to a method for detecting azacitidine impurities, and belongs to the technical field of azacitidine quality control. The invention provides a method for detecting azacitidine impurities, which adopts liquid chromatography, a stationary phase is unterminated octadecylsilane chemically bonded silica, a mobile phase is aqueous phase-acetonitrile = (85-92): (8-15), v/v, and an ion pair reagent sodium octanesulfonate is added in the aqueous phase. Compared with the prior art, the detection method has the advantages that three azacitidine impurities can be simultaneously detected, so that the analysis cost is saved, the sensitivity is high, the operation is simple and convenient, the separation degree and the accuracy both meet the requirements, the symmetry of the peak shapes of the impurities is good, the concentration of a test sample is greatly reduced, the tolerance of a chromatographic column is prolonged, the service life of the chromatographic column is prolonged, and the like. 本发明涉及一种