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Method for detecting disodium ethylene diamine tetraacetate contained in acetylcysteine aerosol inhalation solution

A technology of disodium ethylenediaminetetraacetate and acetylcysteine, which is applied in measurement devices, instruments, scientific instruments, etc., can solve the problem of inability to establish a test method for the test sample, affecting the generation of reaction products, and interfering with the detection of target products, etc. problems, to achieve the effect of ensuring product quality, stable response, and quality control

Inactive Publication Date: 2020-11-24
YANGZHOU ZHONGBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

We have also done related experiments and found that while copper sulfate or ferric chloride and disodium ethylenediamine tetraacetate undergo complexation reactions, they will also undergo redox reactions with acetylcysteine, which seriously affects the quality of the reaction products. Generated, unable to establish the test method for the test article
The study found that using high-performance liquid chromatography, there are many peaks in the chromatogram of the acetylcystine nebulized inhalation solution for the test solution, which will interfere with the detection of the target product

Method used

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  • Method for detecting disodium ethylene diamine tetraacetate contained in acetylcysteine aerosol inhalation solution
  • Method for detecting disodium ethylene diamine tetraacetate contained in acetylcysteine aerosol inhalation solution
  • Method for detecting disodium ethylene diamine tetraacetate contained in acetylcysteine aerosol inhalation solution

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Embodiment 1

[0038] Embodiment 1: detection method of the present invention

[0039] Chromatographic column: Octadecylsilane bonded silica gel (Waters ODS-2 column, 4.0mm×250mm, 5μm);

[0040] Mobile phase A: Accurately measure 5.0 mL of 40% tetrabutylammonium hydroxide solution, add water to dilute to 1000 mL, and adjust the pH value to 2.5 with phosphoric acid;

[0041] Mobile phase B: acetonitrile;

[0042] Column temperature: 30°C;

[0043] Detector: UV detector;

[0044] Flow rate: 1.0mL / min;

[0045] Detection wavelength: 260nm;

[0046] Injection volume: 20μL;

[0047] Elution method: isocratic elution, the volume ratio of mobile phase A and mobile phase B is 88:12.

[0048] Preparation of reference solution: newly prepared before use. Take an appropriate amount of disodium edetate reference substance, add water to dissolve and quantitatively dilute to make a solution containing about 1.0 mg per 1 mL, and use it as a disodium edetate stock solution. Weigh about 40 mg of vita...

Embodiment 2

[0053] Embodiment 2: Investigation of the specificity of the detection method of the present invention

[0054] Preparation of reference solution: newly prepared before use. Take an appropriate amount of disodium edetate reference substance, add water to dissolve and quantitatively dilute to make a solution containing about 1.0 mg per 1 mL, and use it as a disodium edetate stock solution. Weigh about 40 mg of vitamin C, put it in a 25 mL measuring bottle, accurately add 1.0 mL of disodium edetate stock solution, add 15 mL of water to dissolve, shake well, add 2.0 mL of 0.1mol / L ferric chloride solution, shake well, Add water to dilute to the mark, shake well, that is.

[0055] Preparation of the test solution: freshly prepared before use. Weigh about 40 mg of vitamin C, put it in a 25 mL measuring bottle, accurately add 1.0 mL of acetylcysteine ​​atomized inhalation solution, add 15 mL of water to dissolve, shake well, add 2.0 mL of 0.1mol / L ferric chloride solution, shake wel...

Embodiment 3

[0059] Embodiment 3: Inspection of the linear range of the detection method of the present invention

[0060] Take an appropriate amount of disodium edetate reference substance, add water to dissolve and quantitatively dilute to make a solution containing about 1.0 mg per 1 mL, and use it as a disodium edetate stock solution. Weigh 5 parts of vitamin C, about 40 mg each, and put them into five 25 mL measuring bottles, add 0.5 mL, 0.8 mL, 1.0 mL, 1.5 mL, 2.0 mL of disodium edetate stock solution precisely, and then Add 15mL of water to dissolve, shake well, add 2.0mL of 0.1mol / L ferric chloride solution, shake well, add water to dilute to the mark, shake well, as a series of linear solutions. Precisely measure the above-mentioned series of linear solutions, according to the chromatographic conditions of Example 1, sequentially inject and analyze from low concentration to high concentration, record the chromatogram, take the concentration C (μg / mL) of disodium edetate reference ...

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Abstract

The invention belongs to the technical field of chemical drug analysis, and relates to a method for detecting disodium ethylene diamine tetraacetate contained in an acetylcysteine aerosol inhalation solution. High performance liquid chromatography is adopted for detection, and the chromatographic conditions are as follows: chromatographic column: octadecylsilane chemically bonded silica is used asa filler; a mobile phase A: precisely measuring 5.0 mL of a 40% tetrabutylammonium hydroxide solution, adding water to dilute the solution to 1000 mL, and adjusting the pH value to 2.5 with phosphoric acid; a mobile phase B: acetonitrile; the column temperature: 30 DEG C; the detector: an ultraviolet detector; the flow rate: 1.0 mL / min; the detection wavelength: 260 nm; the sample size: 20 [mu] L; the elution mode: isocratic elution, and the volume ratio of the mobile phase A to the mobile phase B is 88: 12. By adopting the high performance liquid chromatography, the target product peak can be effectively separated from other peaks in the test solution.

Description

technical field [0001] The invention belongs to the technical field of chemical drug analysis, and relates to a method for detecting disodium edetate contained in acetylcysteine ​​atomized inhalation solution. Background technique [0002] Acetylcysteine ​​(Acetylcysteine) has been widely used clinically as an expectorant since the 1960s, and it is an expectorant with the most comprehensive mechanism of action in clinical practice. [0003] The sulfhydryl group in the structure of acetylcysteine ​​is very active. In the presence of an oxidizing agent, the sulfhydryl groups in the two acetylcysteine ​​molecules can form a disulfide bond to generate acetylcysteine. Therefore, enterprises usually add a certain amount of disodium ethylenediaminetetraacetate as a metal chelating agent in the process of producing acetylcysteine ​​atomized inhalation solution, which plays an anti-oxidant and stabilizing role in the pharmaceutical dosage form. Disodium edetate is easy to chelate wi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8675G01N2030/065G01N2030/067
Inventor 刘雪张冠亚张广明陈菊芳
Owner YANGZHOU ZHONGBAO PHARMA
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