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Method for determining content of disodium ethylenediamine tetraacetate in posaconazole injection

A technology for disodium EDTA and posaconazole injection, which is applied in the field of content determination of disodium EDTA, can solve the problems of affecting the recovery rate, complicated operation and the like, and achieve the effect of eliminating the influence

Active Publication Date: 2020-11-17
SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It has been reported in the literature that SBE-β-CD in the sample can be removed by anion-exchange solid-phase extraction method and capped cyclohexyl solid-phase extraction cartridge, but the operation is complicated, and the amount of EDTA-2Na in posaconazole injection is small and the extraction is difficult. Process is likely to affect its recovery rate

Method used

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  • Method for determining content of disodium ethylenediamine tetraacetate in posaconazole injection
  • Method for determining content of disodium ethylenediamine tetraacetate in posaconazole injection
  • Method for determining content of disodium ethylenediamine tetraacetate in posaconazole injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Preparation of standard curve of reference substance:

[0029] Accurately weigh 12.5mg of EDTA-2Na reference substance (including 11.3mg of EDTA-2Na), put it in a 25ml measuring bottle, add water to dissolve and make to volume, shake well, and make the stock solution. Precisely measure 2.0ml of the stock solution, put it in a 10ml measuring bottle, add water to dissolve and make to volume, shake well, and make a linear stock solution. Accurately measure 0.05, 0.2, 0.5, 1, 2 and 3ml of the linear stock solution respectively, put them in 10ml measuring bottles, add 100 μl of 1% copper sulfate solution (equivalent to 4 μmol of copper sulfate), dilute to volume with water, and shake well to obtain EDTA-2Na concentration of 0.45, 1.81, 4.52, 9.03, 18.06 and 27.10μg / ml serial concentration solution.

[0030] Inject samples separately, record the chromatogram, take the peak area A as the ordinate, and the concentration c as the abscissa, and perform linear regression to obtai...

Embodiment 2

[0032] (1) Prepare the test solution:

[0033] Preparation of posaconazole injection: Weigh 18 mg of EDTA-2Na, add appropriate amount of water to dissolve, add 40 g of sulfobutyl ether beta cyclodextrin sodium, add appropriate amount of water and stir to dissolve, add posaconazole raw material 1.8 g, add hydrochloric acid Appropriate amount, stir to dissolve posaconazole, add sodium hydroxide solution to adjust pH to 2.6, add water to 100ml, and obtain.

[0034] in:

[0035] The content of each component is as follows:

[0036]

[0037] (2) Sample pretreatment: the prepared posaconazole injection is mixed with copper sulfate solution, then sodium hydroxide solution and water are added, mixed, filtered, and the filtrate is collected as the test solution;

[0038] In the described need testing solution of 10ml, the content of each component is: posaconazole injection 1ml, 1% copper sulfate solution is 100 μ l (equivalent to copper sulfate 4 μ mol), 0.1M sodium hydroxide sol...

Embodiment 3

[0049] (1) Prepare the test solution:

[0050] Preparation of posaconazole injection: Weigh 9 mg of EDTA-2Na, add appropriate amount of water to dissolve, add 40 g of sulfobutyl ether beta cyclodextrin sodium, add appropriate amount of water and stir to dissolve, add 1.8 g of posaconazole raw material, add hydrochloric acid Appropriate amount, stir to dissolve posaconazole, add sodium hydroxide solution to adjust pH to 2.6, add water to 100ml, and obtain.

[0051] in:

[0052] The content of each component is as follows:

[0053]

[0054] Others are the same as embodiment 2, the results are shown in figure 2 ; The detection error is 1.0%.

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Abstract

The invention discloses a method for determining the content of ethylenediamine tetraacetic acid disodium salt in posaconazole injection, which comprises the following steps: (1) sample pretreatment:mixing posaconazole injection to be detected with a copper sulfate solution, adding a sodium hydroxide solution and water, performing mixing, performing filtering, and collecting the filtrate as a test solution; (2) elution: injecting the test solution into a chromatographic column, and pumping an eluent for elution; (3) detection: recording the peak area of the ethylenediamine tetraacetic acid disodium salt of the test solution; and (4) result calculation: comparing the test sample with the ethylenediamine tetraacetic acid disodium reference substance standard curve to obtain a detection result. According to the method disclosed by the invention, the residual sulfobutyl ether betadex sodium on the chromatographic column can be basically and completely eluted by adopting a gradient elutionhigh-proportion water phase, the influence of the sulfobutyl ether betadex sodium on the measurement of the disodium ethylene diamine tetraacetate is effectively eliminated, the error of a detectionresult is less than 1.5%, and the application requirements of related fields can be met.

Description

technical field [0001] The invention relates to a method for determining the content of disodium edetate in posaconazole injection, in particular to a method for determining the content of disodium edetate in posaconazole injection by liquid chromatography. Background technique [0002] Disodium Edetate (EDTA-2Na) is widely used as a chelating agent in pharmaceutical preparations, which can chelate copper, iron (Fe 3+ ) and manganese and other trace metal ions, play the role of antioxidant synergist, can significantly reduce the number of insoluble particles in infusion, and improve the stability of drugs in the process of preparation, storage and clinical preparation. [0003] EDTA-2Na is listed as a generally recognized safe (Generally Recognized as Safe, GRAS) substance, recorded in the FDA "Inactive Components Guide", and also approved for non-injection and injectable preparations in the United Kingdom and China. The general concentration of EDTA-2Na used as a chelating...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 赵雁胡裕迪印玺璟施方震朱硕然易婷尹佩钰陶涛
Owner SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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