Method for detecting acetic acid residues in cefotaxime sodium and application of method

The invention discloses a method for detecting acetic acid residues in cefotaxime sodium and application of the method. Acetic acid in a cefotaxime sodium bulk drug or preparation is separated and detected by adopting chromatography; a chromatographic column in the chromatography is a hydrophilic ch...

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Hauptverfasser: FAN ZHAOZE, LIU SONGLIN, WU ZHEN, YU YANPING, DUN WEI, ZHANG LU, GONG DANFENG, XU YONG
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention discloses a method for detecting acetic acid residues in cefotaxime sodium and application of the method. Acetic acid in a cefotaxime sodium bulk drug or preparation is separated and detected by adopting chromatography; a chromatographic column in the chromatography is a hydrophilic chromatographic column, and a mobile phase in the chromatography is a phosphoric acid solution and a polar organic solvent; the pH value of the phosphoric acid solution is 3; in the chromatography, the volume ratio of the phosphoric acid solution to the polar organic solvent is 98: 2 within 0-a minutes; 2, the volume ratio of the phosphoric acid solution to the polar organic solvent is 30: 70 within (a + 0.1) minutes-20 minutes, and the volume ratio of the phosphoric acid solution to the polar organic solvent is 98: 2 within 20.1 minutes-30 minutes; and a is 9 to 11. According to the detection method, acetic acid can be completely separated, and specificity, system applicability, accuracy, acetic acid concentration a