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Method for testing ethylenediamine in lipoic acid injection medicine

A technology of ethylenediamine and injection, which is applied in the detection field, can solve problems such as chromatographic column tailing and peak bifurcation, the sampling system is highly corrosive, and cannot meet the limit requirements, and achieves smooth baseline, low detection limit, The effect of high sensitivity

Active Publication Date: 2018-12-21
CHENGDU BRILLIANT PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the prior art, gas chromatography is used to measure ethylenediamine, but it is very corrosive to the sampling system, and it is easy to tail and peak bifurcation in the chromatographic column, resulting in poor sampling accuracy and unable to meet the limit of ±5% of the labeled amount Require

Method used

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  • Method for testing ethylenediamine in lipoic acid injection medicine
  • Method for testing ethylenediamine in lipoic acid injection medicine
  • Method for testing ethylenediamine in lipoic acid injection medicine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Detection of ethylenediamine content in lipoic acid injection:

[0054] Chromatographic column: RFIC IonPac CG17, 4mm*50mm, CS17, 4mm*250mm;

[0055] Mobile phase: 15mmol / L methanesulfonic acid is mobile phase A, acetonitrile is mobile phase B, and the volume ratio is 9:1;

[0056] Detector: The detector is a conductivity detector with a suppressor CERS500, 4mm;

[0057] Feed volume: 10 μl;

[0058] Column temperature: 30°C;

[0059] Flow rate: 0.8ml / min;

[0060] Detection steps:

[0061] Accurately measure 1ml of this product, put it in a 100ml measuring bottle, add water to dissolve and dilute to the mark, shake well, and use it as the test solution; take another ethylenediamine reference substance, accurately weigh it, add water to dissolve and quantitatively dilute to 66.7μg / ml solution, as the reference solution. Precisely measure 10 μl each of the test solution and the reference solution, inject them into the ion chromatograph, record the chromatogram, and ...

Embodiment 2

[0068] The applicant fully considered the chemical properties of ethylenediamine, and used a conductivity detector to perform the measurement. Due to the material characteristics of ethylenediamine, there is still obvious tailing on the chromatographic column. Therefore, the asymmetry is used as an index to further screen the mobile phase and injection volume. The screening conditions are shown in Table 2.

[0069] Table 2IC chromatographic condition screening

[0070]

[0071] When the applicant investigates the amount of acetonitrile added, when the volume percentage is greater than 10%, the retention time of ethylenediamine will be less than 5min, which is not conducive to detection, and with the increase of the added amount of acetonitrile, the inhibitory signal is enhanced, so it is determined that methyl sulfonate The volume ratio of acid:acetonitrile is 90:10.

[0072] Research finds that with methanesulfonic acid as mobile phase, as the concentration of methanesulf...

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Abstract

The invention relates to a method for testing ethylenediamine in lipoic acid injection medicine, which comprises the following steps: 1) preparing a reference solution of ethylenediamine; 2) preparinga test solution of zinc sulfate injection; 3) using the ion chromatography method to separately detect the reference solution and the test solution, and calculate the ethylenediamine dose. The conditions for ion chromatography include the following: in chromatography column the stationary phase is a cation exchange resin or a chemically bonded ion exchanger; the mobile phase includes the methanesulfonic acid in mobile phase A and the methanol or acetonitrile in mobile phase B; the volume ratio of mobile phase A to mobile phase B is 90-98:10-2. The ion chromatography method is effective in testing ethylenediamine. The result is accurate, with smooth baseline, symmetrical peak shapes, high stability, good repeatability and high sensitivity.

Description

technical field [0001] The invention relates to the field of detection methods, in particular to a method for detecting ethylenediamine. Background technique [0002] Ethylenediamine, colorless or yellowish oily or watery liquid, has an odor similar to ammonia, and has a boiling point of 116-117.2°C. It is strongly alkaline and corrosive. It is mainly used as a solvent and analytical reagent. [0003] [0004] Ethylenediamine is a commonly used pH adjuster and co-solvent in drugs. The Food and Drug Administration requires a special method to control the content of ethylenediamine in drug approval, and tighten the limit. In the prior art, gas chromatography is used to measure ethylenediamine, but it is very corrosive to the sampling system, and it is easy to tail and peak bifurcation in the chromatographic column, resulting in poor sampling accuracy and unable to meet the limit of ±5% of the labeled amount Require. Contents of the invention [0005] At present, there i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 童庆国徐立宁罗鸣李英富苏忠海
Owner CHENGDU BRILLIANT PHARMA CO LTD
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