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Method for detecting cefixime polymer impurity

A technology of cefixime and polymers, which is applied in the field of drug quality testing, and can solve problems such as poor peak shapes of cefixime polymers

Active Publication Date: 2022-04-22
GUANGZHOU BAIYUNSHAN PHARMA HLDG CO LTD BAIYUNSHAN PHARMA GENERAL FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is evident from the chromatogram that the peak shape of the cefixime polymer is poor

Method used

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  • Method for detecting cefixime polymer impurity
  • Method for detecting cefixime polymer impurity
  • Method for detecting cefixime polymer impurity

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] The preparation of embodiment 1 stock solution

[0064] Preparation of diluent solution: 0.075 mol / L anhydrous disodium hydrogen phosphate: 0.075 mol / L anhydrous sodium dihydrogen phosphate=61:39.

[0065] Sensitivity solution preparation: Accurately measure an appropriate amount of the control solution, dilute it with a diluent to make a solution containing about 0.5 mg of cefixime per 1 ml, and use it as a sensitivity solution.

[0066] Preparation of test solution: get cefixime granules (G1802001 batch), add appropriate amount of diluent, dissolve by ultrasonic, dilute with diluent to make a solution containing cefixime 1mg per 1ml, filter, discard 2.0ml First filtrate, get the continued filtrate as need testing solution;

[0067] Preparation of control solution: Accurately measure an appropriate amount of the test solution, and dilute it with a diluent to prepare a solution containing about 1 μg of cefixime per 1 ml, as a control solution.

[0068] Preparation of ...

Embodiment 2

[0069] Embodiment 2 system suitability test

[0070] Take an appropriate amount of cefixime polymer system suitability reference substance, add phosphate buffer (0.075mol / L anhydrous disodium hydrogen phosphate: 0.075mol / L anhydrous sodium dihydrogen phosphate=61:39) to dissolve and dilute to prepare Each 1ml contains about 1mg of cefixime, 2mg of polymer impurity B and 2mg of dimer D, take 20ml and inject it into the liquid chromatograph, record the chromatogram, the separation degree of polymer impurity B and dimer D should meet Require.

Embodiment 3

[0071] The detection of polymer impurity in the cefixime granule of embodiment 3

[0072] Chromatographic column: Hypersil Gold C18, 4.6mm×250mm, 3μm;

[0073] Mobile phase: mobile phase A is 0.1% formic acid solution, and mobile phase B is acetonitrile.

[0074] Flow rate: 1.0ml / min;

[0075] Detection wavelength: 254nm;

[0076] Column temperature: 35°C;

[0077] Injection volume: 20 μL.

[0078] Gradient elution program: as shown in Table 3.

[0079] Table 3 Gradient elution program

[0080]

[0081]

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Abstract

The invention relates to the technical field of drug quality detection, in particular to a method for detecting cefixime polymer impurities. The method includes detection by high performance liquid chromatography, and the detection conditions of the high performance liquid chromatography include: mobile phase: composed of mobile phase A and mobile phase B, wherein mobile phase A is formic acid solution, and mobile phase B is acetonitrile , methanol or acetonitrile-methanol; the volume ratio of mobile phase A and mobile phase B is 20~95:80~5. The method for detecting cefixime polymer impurities provided by the invention can effectively detect cefixime polymer impurities, and solve the problem that the original detection method has poor specificity and most of the detected impurities are not polymer impurities.

Description

technical field [0001] The invention relates to the technical field of drug quality detection, in particular to a method for detecting cefixime polymer impurities. Background technique [0002] Cefixime (Cefixime) belongs to β-lactam antibiotics, is the third generation cephalosporin antibiotics, its chemical name is: (6R,7R)-7-[(Z)-2-(2-amino-4 -Thiazolyl)-2-(carboxymethoxyimino)acetamido]-8-oxo-3-ethylene-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2- Carboxylic acid trihydrate; it has the characteristics of long half-life, high efficiency and low toxicity, wide distribution in the body, and good tissue penetration. [0003] The sources of polymer impurities in cephalosporin antibiotics can be divided into two categories: exogenous impurities and endogenous impurities. Exogenous impurities generally originate from the fermentation process, which are impurities combined with antibiotics such as proteins, polypeptides, and polysaccharides; endogenous impurities refer to the polyme...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/06G01N30/74G01N30/88
CPCG01N30/06G01N30/74G01N30/88
Inventor 胡海容苏燕琼高琳王健松蔡国伟叶伟文李卓
Owner GUANGZHOU BAIYUNSHAN PHARMA HLDG CO LTD BAIYUNSHAN PHARMA GENERAL FACTORY
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