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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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 |
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