Detection method of glucose related substances in acetate compound electrolyte injection

A compound electrolyte and related substance technology, which is applied in the detection field of glucose-related substances in acetate compound electrolyte injection, can solve problems such as unstable retention time of acetate and influence on glucose product detection, and improve product quality and safety Sexuality, the effect of optimizing the process

Inactive Publication Date: 2018-12-18
HUAREN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The invention provides a method for detecting glucose-related substances in acetate compound electrolyte injection, which solves the technical problem in the prior art that the retention time of acetate is extremely unstable and affects the detection of glucose-related products in compound electrolyte injection

Method used

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  • Detection method of glucose related substances in acetate compound electrolyte injection
  • Detection method of glucose related substances in acetate compound electrolyte injection
  • Detection method of glucose related substances in acetate compound electrolyte injection

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Embodiment 1

[0017] A method for detecting glucose-related substances in acetate compound electrolyte injection, comprising the following steps:

[0018] (1) Preparation of system suitability solution: Weigh 24 mg of sodium acetate reference substance, 1 mg of maltotriose reference substance, 1 mg of maltose and isomaltose, 100 mg of glucose reference substance and 2 mg of fructose reference substance, put them in a 10ml measuring bottle, and dilute with water to the mark , shake well, as a system suitability solution.

[0019] (2) Preparation of the test product and self-reference solution: directly take the sample as the test solution, the glucose concentration in the sample is about 10mg / ml; accurately measure 1ml of the test solution, put it in a 50ml volumetric flask, and dilute it with water to the mark , shake well, as control solution A; accurately measure 5ml of control solution A, put it in a 100ml volumetric flask, dilute with water to the mark, shake well, and use it as control...

Embodiment 2

[0023] A method for detecting glucose-related substances in acetate compound electrolyte injection, comprising the following steps:

[0024] (1) Preparation of system suitability solution: Weigh 24 mg of sodium acetate reference substance, 1 mg of maltotriose reference substance, 1 mg of maltose and isomaltose, 100 mg of glucose reference substance and 2 mg of fructose reference substance, put them in a 10ml measuring bottle, and dilute with water to the mark , shake well, as a system suitability solution.

[0025] (2) Preparation of test sample and self reference solution: directly take the sample as the test solution, the glucose concentration in the sample is about 10mg / ml; accurately measure 1ml of the test solution, put it in a 50ml volumetric flask, and dilute with water to the mark , shake well, as control solution A; accurately measure 5ml of control solution A, put it in a 100ml volumetric flask, dilute with water to the mark, shake well, and use it as control solutio...

Embodiment 3

[0029] A method for detecting glucose-related substances in acetate compound electrolyte injection, comprising the following steps:

[0030] (1) Preparation of system suitability solution: Weigh 24 mg of sodium acetate reference substance, 1 mg of maltotriose reference substance, 1 mg of maltose and isomaltose, 100 mg of glucose reference substance and 2 mg of fructose reference substance, put them in a 10ml measuring bottle, and dilute with water to the mark , shake well, as a system suitability solution.

[0031] (2) Preparation of test sample and self reference solution: directly take the sample as the test solution, the glucose concentration in the sample is about 10mg / ml; accurately measure 1ml of the test solution, put it in a 50ml volumetric flask, and dilute with water to the mark , shake well, as control solution A; accurately measure 5ml of control solution A, put it in a 100ml volumetric flask, dilute with water to the mark, shake well, and use it as control solutio...

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Abstract

The invention provides a detection method of glucose related substances in an acetate compound electrolyte injection, related to the technical field of medicine. The detection method of glucose related substances in the acetate compound electrolyte injection comprises the following steps: preparing a system suitability solution: weighing a sodium acetate reference substance, a glucose reference substance and a glucose degradation product reference substance, placing in a 10ml volumetric flask, diluting to a mark with water, shaking well, and taking as the system suitability solution; preparinga test substance and a self reference solution: taking the sample directly for the test substance solution; measuring and taking the test substance solution, placing in a 50ml volumetric flask, diluting to the mark with water, shaking well as a contrast solution A; taking a portion of the contrast solution A, placing in a 100ml volumetric flask, diluting to the mark with water, and shaking well as a contrast solution B; and chromatographic conditions are as follows: Waters Sugar Park I column, 300mm x 6.5mm, 10[Mu]m; mobile phase, 50 mg/L aqueous solution of calcium ethylenediaminetetraacetate; flow rate, 0.3 ml/min; column temperature, 85+/-5 degrees centigrade; differential detector set temperature, 40+/-5 degrees centigrade; and injection volume, 20[Mu]l. The detection method of glucose related substances in the acetate compound electrolyte injection has the beneficial effects of effectively separating the acetate and the glucose degradation products, optimizing the process and improving the product quality and safety.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for detecting glucose-related substances in acetate compound electrolyte injection. Background technique [0002] Impurities in the drug affect the drug stability and drug safety. For the degradation products of glucose, the United States Pharmacopoeia USP40 provides the detection method and limit of related substances of glucose raw materials. The specific method is: weigh an appropriate amount of anhydrous glucose Determine, make a solution containing about 30 mg of anhydrous glucose in every 1 ml with water, as the reference solution A; accurately measure 5 ml of this product, put it in a 10 ml measuring bottle, dilute to the mark with water, shake well, and use it as the test solution; Take 1ml of the test solution, put it in a 250ml volumetric flask, dilute it with water to the mark, shake it up, and use it as contrast solution B; accurately measure 25ml of the con...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 李婷婷冯新光刘春霞叶芳
Owner HUAREN PHARMACEUTICAL CO LTD
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