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Method for detecting cefixime and related substances

A related substance, cefixime technology, applied in the field of drug analysis, can solve the problems such as difficult elution of impurities, achieve good accuracy and benefit quality control

Inactive Publication Date: 2019-06-18
BEIJING JIMEITANG MEDICINE RES CO LTD
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  • Abstract
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Problems solved by technology

[0011] 4. Limits of related substances recorded in pharmacopoeias of various countries
[0013] 5. The detection methods of cefixime-related substances recorded in the pharmacopoeias of the above countries have the same mobile phase system and are all isocratic elutions. The organic phase ratio is up to 28%, and the less polar impurities in the sample are difficult to elute.

Method used

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  • Method for detecting cefixime and related substances
  • Method for detecting cefixime and related substances
  • Method for detecting cefixime and related substances

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Embodiment

[0038] Chromatographic conditions:

[0039] Instrument: Shimadzu 20A, Shimadzu 20AvT UV detector, detection wavelength: 254nm;

[0040] Column: Octadecyl-bonded silica gel-bonded silica filler, Shimadzu 4.6×250mm, 5μm;

[0041] Mobile phase A: acetonitrile-tetrabutylammonium hydroxide solution (take 25ml of 10% tetrabutylammonium hydroxide, add water to dilute to 1000ml, adjust the pH value to 7.0 with 1.5mol / L phosphoric acid) (28:72);

[0042] Mobile phase B: acetonitrile;

[0043] Linear gradient elution:

[0044]

[0045]

[0046] Flow rate: 1.0mL / min;

[0047] Column temperature: 40°C;

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Abstract

The invention provides a novel method for detecting cefixime and related substances by means of high-performance liquid phase separation and ultraviolet detection in series. The method has good stability, good reproducibility and simple operation, and impurities with relatively small polarities can be accurately detected, which is conducive to the quality control of drugs.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and relates to a method for detecting related substances of cefixime, a third-generation cephalosporin antibiotic. At present, the detection methods of relevant substances in pharmacopoeias of various countries adopt isocratic elution, and it is difficult to elute impurities with low polarity. Systematic methodology validation. Background technique [0002] Cefixime is an oral third-generation cephalosporin antibiotic with the following structural formula: [0003] [0004] In order to effectively control product quality, it is necessary to strictly control its impurity content. At present, the quality standards of cefixime are recorded in the pharmacopoeias of various countries, and the chromatographic conditions for the detection of relevant substances and the limits of impurities are as follows: [0005] 1. Chromatographic conditions for related substances recorded in the quality s...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/38
Inventor 赵亚翡张雪姚云凡
Owner BEIJING JIMEITANG MEDICINE RES CO LTD
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