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 cartr

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

Example Embodiment

[0027] Example 1

[0028] Preparation of standard curve of reference substance:

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

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

Example Embodiment

[0031] Example 2

[0032] (1) Prepare test solution:

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

[0034] among them:

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

[0036]

[0037] (2) Sample pretreatment: mix the prepared posaconazole injection with copper sulfate solution, then add sodium hydroxide solution and water, mix, filter, and collect the filtrate as the test solution;

[0038] In 10ml of the test solution, the content of each component is: posaconazole injection 1ml, 1% copper sulfate solution 100μl (equivalent to copper sulfate 4μmol), 0.1M sodium hydroxide solution 400μl (equivalent to Sodiu...

Example Embodiment

[0048] Example 3

[0049] (1) Prepare test solution:

[0050] Preparing posaconazole injection: weigh 9mg of EDTA-2Na, add appropriate amount of water to dissolve, add 40g of sulfobutyl ether beta cyclodextrin sodium, add appropriate amount of water and stir to dissolve, add 1.8g of posaconazole crude drug, add hydrochloric acid Appropriate amount, stir to dissolve posaconazole, add sodium hydroxide solution to adjust the pH to 2.6, and then add water to 100ml to get.

[0051] among them:

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

[0053]

[0054] Others are the same as in Example 2, see the results 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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