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A method for detecting related substances of cefodizime sodium

A technology of cefodizime sodium and related substances, which is applied in the detection field of cefodizime sodium related substances, can solve problems such as difficult to deal with and accelerate the separation of complex components, and achieve good reproducibility and good separation

Active Publication Date: 2017-06-30
SUZHOU ERYE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Although this method can effectively separate cefodizime and related substances, it is difficult to deal with the separation of complex components under accelerated test conditions such as acid, alkali, and high temperature damage.

Method used

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  • A method for detecting related substances of cefodizime sodium

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Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0019] Need testing solution: take an appropriate amount of cefodizime sodium for injection, dissolve it with water for injection and quantitatively dilute it into a solution of 0.5 mg / ml;

[0020] Mobile phase A: 5mmol / L diammonium hydrogen phosphate solution;

[0021] Mobile phase B: acetonitrile;

[0022] Chromatographic column: 200mm×4.6 mm, 5 μm;

[0023] Filler: C18 alkyl silane bonded silica gel;

[0024] Column temperature: 25°C;

[0025] Detection wavelength: 262nm;

[0026] Flow rate: 1.0mL / min;

[0027] Gradient elution conditions:

[0028] time / min Mobile phase A (%) Mobile phase B (%) 0 95 5 15 80 20 20 80 20 25 95 5 30 95 5

[0029] Take 20 μl of the above-mentioned test solution, inject it into a high-performance liquid chromatograph, and record the chromatogram.

[0030] The attribution of the impurity peaks was identified by the internal standard method, and the results were as follows:

[0031] ...

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Abstract

The invention relates to a method for detecting related substances of cefodizime sodium, which adopts diammonium hydrogen phosphate and acetonitrile as mobile phases for gradient elution, and can realize effective separation of cefodizime and related substances.

Description

technical field [0001] The invention relates to a method for detecting related substances of cefodizime sodium. Background technique [0002] Cefodizime sodium (cefodizime), as the third-generation cephalosporin, was first successfully developed by the German HoechstRoussel company in the world. It was approved to be marketed in Japan in 1990 (trade name: Neucef), and it was approved to be imported into China in 1994. It has been in clinical application for nearly 20 years. [0003] The currently known impurities of this product are: 2-mercapto-4-methyl-5-thiazoleacetic acid (related substance I) and Δ-2 cefodizime (related substance II). [0004] The existing liquid phase detection condition of cefodizime sodium is to be with phosphate buffer (take potassium dihydrogen phosphate 0.87g and anhydrous disodium hydrogen phosphate 0.22g, add water to dissolve and be diluted to 1000ml, shake up) and acetonitrile 920:80 mixed as mobile phase, isocratic elution. Although this me...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 陈学文沈灏华军杰朱炜
Owner SUZHOU ERYE PHARMA CO LTD