Method for measuring fudosteine related substance by using amino column

The invention discloses a method for measuring a fudosteine related substance by using an amino column and belongs to the technical field of pharmaceutical analysis. A chromatographic column (25cm*4.6mm, 5 microns) taking amino bonded silica gel bonded silica gel as a filler serves as the chromatogr...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser: ZHANG JINGXIA, LI CHENGLONG, TANG KEHUI, XU MINGQIN, LI ZHEYU, ZHANG CHUNRAN, WANG YUCHI, DENG SISI
Format: Patent
Sprache:eng
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Beschreibung
Zusammenfassung:The invention discloses a method for measuring a fudosteine related substance by using an amino column and belongs to the technical field of pharmaceutical analysis. A chromatographic column (25cm*4.6mm, 5 microns) taking amino bonded silica gel bonded silica gel as a filler serves as the chromatographic column used in the method, 0.05mol/L of potassium dihydrogen phosphate solution (the pH of phosphoric acid is adjusted to 4.5) and acetonitrile in the ratio of 35:65 serve as mobile phase, the detection wavelength is 210nm, the flow rate is 1.0mL/min, a high performance liquid chromatography condition is the column temperature of 30 DEG C, and the fudosteine related substance is measured. According to the related substance measuring method provided by the invention, more impurities can be measured, separation degree between a main peak and impurities is better, trace impurities in a sample can be more scientifically and accurately measured, the using safety and the efficiency of the sample are improved, and the method has advanced nature.