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Content determination method of edetate disodium in acetylcysteine liquid preparation

A technology of acetylcysteine ​​and disodium edetate, applied in the field of content determination of disodium edetate, can solve the interference of determination, cannot meet the requirements of content determination, cannot meet the requirements of accurate quantification of disodium edetate, etc. question

Active Publication Date: 2020-02-14
上海聚可医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When using this method to measure the content of edetate disodium in the acetylcysteine ​​solution for inhalation, it is found that the active ingredient acetylcysteine ​​also seriously interferes with the determination of edetate disodium, which cannot meet the content requirements. Determination of relevant requirements
[0012] Therefore, the prior art cannot meet the requirement of accurate quantification of edetate disodium in the acetylcysteine ​​solution for inhalation

Method used

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  • Content determination method of edetate disodium in acetylcysteine liquid preparation
  • Content determination method of edetate disodium in acetylcysteine liquid preparation
  • Content determination method of edetate disodium in acetylcysteine liquid preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] 1. Chromatographic conditions:

[0075] Chromatographic column: Aminosilane bonded silica gel as filler, Agilent 4.6×250mm, filler particle diameter 5μm;

[0076] Column temperature: 25°C;

[0077] Mobile phase: a solution containing 0.1% tetradecyl ammonium bromide and 0.05% tetraheptyl ammonium bromide (phosphoric acid to adjust the pH to 2.0)-methanol (volume ratio 95:5) as the mobile phase;

[0078] Flow rate: 2mL / min;

[0079] Injection volume: 5μL;

[0080] Detection wavelength: 240nm.

[0081] 2. Preparation of test solution:

[0082] (1) Preparation of the test solution: accurately measure 0.2 mL of acetylcysteine ​​solution for inhalation, put it in a 10 mL measuring bottle, add 20 mg of hydroxypropyl-β-cyclodextrin, and then add 0.5% ferric chloride solution 0.4mL, and finally add mobile phase to dilute to the mark, shake well, and filter to obtain the test solution.

[0083] (2) Preparation of reference solution: Take 25 mg of edetate disodium, accurate...

Embodiment 2

[0087] 1. Chromatographic conditions:

[0088] Chromatographic column: Aminoalkylsilane bonded silica gel as filler, Agilent 4.6×250mm, filler particle diameter 5μm; column temperature: 35°C;

[0089] Mobile phase: a solution containing 2% tetradecyl ammonium bromide and 1% tetraheptyl ammonium bromide (phosphoric acid to adjust the pH to 3.0)-methanol (volume ratio 70:30) as the mobile phase;

[0090] Flow rate: 0.5mL / min;

[0091] Injection volume: 50μL;

[0092] Detection wavelength: 280nm.

[0093] 2. Preparation of test solution:

[0094] (1) Preparation of the test solution: Accurately measure 2 mL of acetylcysteine ​​solution for inhalation, put it in a 10 mL measuring bottle, add 200 mg of hydroxypropyl-β-cyclodextrin, and then add 4 mL of 0.5% ferric chloride solution , and finally add mobile phase to dilute to the mark, shake well, and filter to obtain the test solution.

[0095] (2) Preparation of reference solution: Take 25 mg of edetate disodium, accurately wei...

Embodiment 3

[0099] 1. Chromatographic conditions:

[0100] Chromatographic column: Aminoalkylsilane bonded silica gel as filler, Agilent 4.6×250mm, filler particle diameter 5μm;

[0101] Column temperature: 30°C;

[0102] Mobile phase: a solution containing 0.2% tetradecyl ammonium bromide and 0.1% tetraheptyl ammonium bromide (phosphoric acid to adjust the pH to 1.5)-methanol (volume ratio 90:10) as the mobile phase;

[0103] Flow rate: 1mL / min;

[0104] Injection volume: 20μL;

[0105] Detection wavelength: 257nm.

[0106] 2. Test solution preparation:

[0107] (1) Preparation of the test solution: accurately measure 1 mL of acetylcysteine ​​solution for inhalation, put it in a 10 mL measuring bottle, add 100 mg of hydroxypropyl-β-cyclodextrin, and then add 2 mL of 0.5% ferric chloride solution , and finally add mobile phase to dilute to the mark, shake well, and filter to obtain the test solution.

[0108] (2) Preparation of reference solution: Take 25 mg of edetate disodium, acc...

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Abstract

The invention belongs to the field of medicine detection, and discloses a content determination method of edetate disodium in acetylcysteine liquid preparation. In the method, HPLC is used, a test solution is prepared from the acetylcysteine liquid preparation, cyclodextrin and / or cyclodextrin derivatives, Fe3+ and a mobile phase, amino silane bonded silica gel is used as a chromatographic columnof a filler, a mixed solvent of ion pair buffer solution and an organic phase is used as the mobile phase, and thus, content of the edetate disodium in the test solution can be determined. The methodis simple to operate and excellent in repeatability, can accurately determine content of the edetate disodium in the acetylcysteine liquid preparation, and consequently can control product quality ofthe edetate disodium in acetylcysteine liquid preparation better.

Description

technical field [0001] The invention belongs to the technical field of medical detection, and relates to a detection method of metal chelating agents in medicines, in particular to a content determination method of edetate disodium in acetylcysteine ​​liquid preparations. Background technique [0002] At present, edetate disodium, as a commonly used pharmaceutical excipient, is recorded in the Chinese Pharmacopoeia, the British Pharmacopoeia and the European Pharmacopoeia, etc., and it has a structure shown in the following structural formula (I): [0003] [0004] Molecular formula: C l0 h 14 N 2 Na 2 o 8 2H 2 O; [0005] Molecular weight: 372.23. [0006] The routine determination method of edetate disodium content is complexometric titration, and wherein Chinese Pharmacopoeia concrete determination method is: get about 0.4g of this product, weigh accurately, add water 40mL and make to dissolve, add ammonia-ammonium chloride buffer (pH10 .0) 10mL, titrate with z...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 周赟司成桃张宇彤
Owner 上海聚可医药科技有限公司
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