Method for detecting cefodizime sodium related substances

A technology of cefodizime sodium and detection method, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems that are difficult to deal with and accelerate the separation of complex components, and achieve the effect of good reproducibility and good separation

Active Publication Date: 2015-12-02
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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  • Method for detecting cefodizime sodium related substances
  • Method for detecting cefodizime sodium related substances
  • Method for detecting cefodizime sodium related substances

Examples

Experimental program
Comparison scheme
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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×4.6mm, 5μm;

[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] Ch...

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Abstract

The invention relates to a method for detecting cefodizime sodium related substances. Ammonium dibasic phosphate and acetonitrile are served as mobile phases to perform gradient elution; and cefodizime can be effectively separated from the 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 listed 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 current liquid phase detection condition of cefodizime sodium is phosphate buffer (take 0.87g of potassium dihydrogen phosphate and 0.22g of anhydrous disodium hydrogen phosphate, add water to dissolve and dilute to 1000ml, shake well) and acetonitrile at 920: 80 was mixed as the mobile phase and eluted isocratically. Although...

Claims

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Application Information

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