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Method for determining edetate disodium in sodium bicarbonate injection

A technology of disodium ethylenediamine tetraacetate and sodium bicarbonate, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of chromatographic column performance degradation, environmental protection, and high detection cost, and achieve low detection cost and simple method , analyze fast results

Inactive Publication Date: 2019-05-17
JILIN NORMAL UNIV
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Problems solved by technology

[0005] The purpose of the present invention is to provide a method for the determination of disodium ethylenediaminetetraacetic acid in sodium bicarbonate injection, to solve the problem that the existing high liquid chromatography adopts organic solvent and buffer salt as the mobile phase, which is not environmentally friendly and uses buffer for a long time. The performance of the chromatographic column is reduced after salting, and the technical problems of high detection cost

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  • Method for determining edetate disodium in sodium bicarbonate injection
  • Method for determining edetate disodium in sodium bicarbonate injection
  • Method for determining edetate disodium in sodium bicarbonate injection

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Embodiment 1

[0027] A kind of assay method of disodium edetate in sodium bicarbonate injection, concrete operation steps are as follows:

[0028] (1) Preparation of reference substance solution

[0029] Accurately weigh 8.79mg of disodium edetate reference substance, put it in a 50ml volumetric flask, add aqueous solution, dilute to the mark, and prepare a reference substance solution with a concentration of 175.8μg / ml for later use.

[0030] (2) The test solution

[0031] Take sodium bicarbonate injection directly.

[0032] (3) Chromatographic conditions

[0033] Chromatographic column: Sephadex G-10; detector: ultraviolet, detection wavelength: 250nm; column temperature: 30°C; injection volume: 10μl, mobile phase is water (ultrapure water).

[0034] (4) Determination: Accurately draw respectively 10 μl of reference substance solution and need testing solution, inject liquid chromatography, measure, record the chromatogram of 10min (see figure 1 , figure 2 ), calculated by the peak ...

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Abstract

The invention relates to a method for determining edetate disodium in a sodium bicarbonate injection. The method comprises the following specific operation steps of (1) preparing a reference solution,namely taking an edetate disodium reference substance, precisely weighing, putting the edetate disodium reference substance into a volumetric flask, adding an aqueous solution, diluting to the scale,and preparing the reference solution with the concentration of 175.8 micrograms per milliliter; (2) providing a test solution, namely directly taking the sodium bicarbonate injection; (3) providing chromatographic conditions that a chromatographic column is glucan gel, the detection wavelength of an ultraviolet detector is 250 nm and the column temperature is 30 DEG C, the injection size is 10 microliters, and the flowing phase is water; and (4) determining, namely respectively precisely sucking 10 microliters of the reference solution and 10 microliters of the test solution, injecting into the reference solution and the test solution into a liquid chromatogram, and determining. Compared with the prior art, the method is simple, accurate, good in reproducibility and stability, low in detection cost, rapid in analysis of a detection result, free of organic solvent in the whole process, and more environment-friendly.

Description

technical field [0001] The invention relates to a detection method for disodium edetate, in particular to a method for determining disodium edetate in sodium bicarbonate injection. Background technique [0002] Disodium edetate, also known as disodium edetate, is an important complexing agent used in electroless plating, detergents, water purifiers, pH regulators, anticoagulants, etc., and used in injections to stabilize It can effectively enhance the stability of the drug. The principle is that disodium edetate can form a stable water-soluble chelate with metal ions, which can prevent its own oxidation, and is beneficial to improve the process of drug preparation, storage and clinical preparation. in the stability. [0003] However, since disodium edetate can irritate the mucous membranes, upper respiratory tract, eyes and skin, long-term use of disodium edetate products exceeding the standard may have adverse effects on human health. In addition, disodium edetate can als...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 孙艳涛赵磊王路宏高秀红郭彩芳张进李文君
Owner JILIN NORMAL UNIV
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