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Method for detecting triethylamine in cefotaxime sodium and application of method

A technology of cefotaxime sodium and detection method, which is applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the problems of poor specificity, ineffective separation, cumbersome operation process, etc., and achieves the effect of good peak shape and separation degree.

Inactive Publication Date: 2020-10-30
武汉九州钰民医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The technical problem to be solved by the present invention is to overcome the residual triethylamine detection method in the cefotaxime sodium bulk drug that exists in the prior art. Detection method and application of triethylamine in

Method used

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  • Method for detecting triethylamine in cefotaxime sodium and application of method
  • Method for detecting triethylamine in cefotaxime sodium and application of method
  • Method for detecting triethylamine in cefotaxime sodium and application of method

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Experimental program
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Effect test

Embodiment 1

[0040] (1) Chromatographic conditions

[0041] Chromatographic column: Agilent CP-Sil 8 CB, 30m×0.32mm, 1.0μm;

[0042] Carrier gas flow rate: 3.0mL / min;

[0043] Heating program: maintain 50°C for 5 minutes, raise the temperature to 150°C at a rate of 10°C / min, then raise the temperature to 250°C at a rate of 25°C / min, and maintain for 3 minutes;

[0044] Injection port temperature: 200°C;

[0045] Detector temperature: 250°C;

[0046] Split ratio: 20:1;

[0047] Headspace furnace temperature: 80°C;

[0048] Headspace equilibration time: 30min;

[0049] Diluent: 4mol / L potassium hydroxide solution-dimethyl sulfoxide (1:1).

[0050] (2) Solution preparation

[0051] 1) Reference substance solution: weigh an appropriate amount of triethylamine, and use a diluent to prepare a solution containing about 32 μg / mL of triethylamine per 1 mL;

[0052] 2) Test solution: Weigh an appropriate amount of this product, and use a diluent to prepare a solution containing about 100 mg ...

Embodiment 2

[0079] Embodiment 2 residual triethylamine methodological verification

[0080] (1) Specificity

[0081] Prepare and test the specificity of the following solutions respectively:

[0082] Blank (prepared according to the method)

[0083] Control solution (prepared according to the method)

[0084] The test solution (prepared according to the method)

[0085] Exclusive solution (containing the test solution of limit concentration triethylamine)

[0086] Triethylamine positioning solution (limit concentration)

[0087] Methanol positioning solution (limit concentration)

[0088] Ethanol positioning solution (limit concentration)

[0089] Acetone positioning solution (limit concentration)

[0090] Dichloromethane positioning solution (limit concentration)

[0091] Ethyl acetate positioning solution (limit concentration)

[0092] Preparation of Specificity and Positioning Solutions

[0093] 1. Control stock solution: Accurately weigh 28.0mg of triethylamine, put it in a ...

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Abstract

The invention discloses a method for detecting triethylamine in cefotaxime sodium and application of the method. According to the method for detecting triethylamine in cefotaxime sodium, gas chromatography detection is carried out in a headspace sample injection mode, and the chromatographic column is one of Agilent CP-Sil 8 CB with 30m * 0.32 mm and 1.0 micron or a chromatographic column with equivalent efficiency; the detection process comprises the following steps: injecting a triethylamine reference substance solution and a cefotaxime sodium test solution into a gas chromatograph in a headspace sample injection manner, and performing detecting according to an external standard method. According to the method for detecting residual triethylamine in cefotaxime sodium, to-be-detected triethylamine in cefotaxime sodium can be effectively separated, and the peak shape and the separation degree are good.

Description

technical field [0001] The invention relates to a detection method and application of triethylamine in cefotaxime sodium. Background technique [0002] According to the control of the cefotaxime sodium bulk drug in the pharmacopoeias of various countries at present, triethylamine is all lacked to be controlled, therefore lacks corresponding detection method, and the cefotaxime sodium bulk drug has used solvent triethylamine in the synthetic process, therefore There are residues of triethylamine in the finished product, and the existing chromatographic method has defects in the quantification of triethylamine, and the tailing on the peak shape is serious, which affects its effective quantitative calculation. Contents of the invention [0003] The technical problem to be solved by the present invention is to overcome the residual triethylamine detection method in the cefotaxime sodium bulk drug that exists in the prior art. The detection method and application of triethylam...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/30G01N30/32G01N30/68G01N30/86
CPCG01N30/02G01N30/06G01N30/30G01N30/32G01N30/68G01N30/8675G01N2030/324
Inventor 吴珍余艳平范昭泽刘松林柳少群龚丹凤杨子贤张璐顿伟许勇
Owner 武汉九州钰民医药科技有限公司
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