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Method for detecting content, dissolution rate and releasing rate of memantine hydrochloride or analogues thereof in medicinal agent

A technology of memantine hydrochloride and release degree, applied in measuring devices, instruments, scientific instruments, etc., can solve the problems of high price, inconvenient use, generation of harmful waste gas, etc. Effect

Inactive Publication Date: 2015-09-30
ZHUHAI UNITED LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the evaporative light scattering detector is used in the inventive method, which is expensive and inconvenient to use, and high-pressure nitrogen or air must be configured in the experiment, and some harmful exhaust gases will be generated in the experiment

Method used

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  • Method for detecting content, dissolution rate and releasing rate of memantine hydrochloride or analogues thereof in medicinal agent
  • Method for detecting content, dissolution rate and releasing rate of memantine hydrochloride or analogues thereof in medicinal agent
  • Method for detecting content, dissolution rate and releasing rate of memantine hydrochloride or analogues thereof in medicinal agent

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0048] Experimental example 1 detection method verification test:

[0049] 1. Validation of the method

[0050] (1) Chromatographic conditions and system suitability test

[0051] Instruments and reagents: Shimadzu high performance liquid chromatography (LC-20AT infusion pump, SIL-20AC autosampler, CTO-20AC column thermostat, RID-10A differential refractive index detector), Kromasil C8 column (250mnx4.6mm, 5μm), the mobile phase is methanol-0.05mol / L potassium dihydrogen phosphate solution (57:43), the flow rate is 1.0ml / min, the column temperature is 35°C, and the detection cell temperature is 40°C.

[0052] Under this chromatographic condition, the main peak shape of memantine hydrochloride is normal, and the retention time is about 8 minutes, which is relatively moderate. The number of theoretical plates is greater than 1500 based on the peak of memantine hydrochloride. The resolution of the memantine hydrochloride peak and adjacent impurity peaks met the analysis requir...

Embodiment 1

[0073] Embodiment 1: memantine hydrochloride tablet (specification: 10mg) assay

[0074] 1.1 Drugs and reagents:

[0075] Drugs: The test product is memantine hydrochloride tablets, produced by Zhuhai United Laboratories Co., Ltd. Zhongshan Branch; the reference substance memantine hydrochloride is from Zhuhai United Laboratories Co., Ltd.

[0076] Reagents: Potassium dihydrogen phosphate is of analytical grade, methanol is of chromatographic grade.

[0077] 1.2 Chromatographic conditions and system suitability test:

[0078] Chromatographic column: Kromasil C8 column (250mnx4.6mm, 5μm); methanol-0.05mol / L potassium dihydrogen phosphate solution (57:43) is used as the mobile phase, the detector is a differential refractive index detector, and the flow rate is 1.0ml per minute. The column temperature was 35°C, and the detection cell temperature was 40°C.

[0079] 1.3 Preparation of reference solution:

[0080] Accurately weigh about 20 mg of the reference substance, put it ...

Embodiment 2

[0088] Embodiment 2: memantine hydrochloride oral solution (specification: 120ml: 240mg) content determination

[0089] 2.1 Drugs and reagents:

[0090]Drugs: The test product is memantine hydrochloride oral solution, produced by Zhuhai United Laboratories Co., Ltd. Zhongshan Branch; the reference substance memantine hydrochloride is from Zhuhai United Laboratories Co., Ltd.

[0091] Reagents: Potassium dihydrogen phosphate is of analytical grade, methanol is of chromatographic grade.

[0092] 2.2 Chromatographic conditions and system suitability test:

[0093] Chromatographic column: Kromasil C8 column (250mnx4.6mm, 5μm); methanol-0.05mol / L potassium dihydrogen phosphate solution (57:43) is used as the mobile phase, the detector is a differential refractive index detector, and the flow rate is 1.0ml per minute. The column temperature was 35°C, and the detection cell temperature was 40°C.

[0094] 2.3 Preparation of reference solution:

[0095] Preparation of Reference Sub...

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Abstract

The invention relates to the chemistry field and in particular relates to a method for detecting memantine hydrochloride or analogues thereof in a medicinal agent. A method for detecting the content, the dissolution rate and the releasing rate of memantine hydrochloride or analogues thereof in medicinal agent adopts the liquid chromatogram conditions as follows: a detector is a differential refraction detector, a chromatographic column takes octyl silane bonded silica gel as a filler, and the moving phase is methanol-0.05mol / L monopotassium phosphate solution. The method is rapid, convenient and accurate and has strong operational practicability.

Description

technical field [0001] The invention relates to a method for detecting the content, dissolution rate or release rate of memantine hydrochloride-related preparations, belonging to the field of chemical drug analysis. Background technique [0002] Memantine hydrochloride is an N-formylaspartate receptor (NMDA) antagonist, which can block the pathological increase of glutamate level caused by abnormal nerve function, effectively regulate excitatory transmitters, and slow down the process of neurodegeneration, thereby Improve cognitive function. It is used for the treatment of moderate to severe Alzheimer's dementia (senile dementia), which is clinically characterized by memory loss, cognitive dysfunction, abnormal mental behavior, etc., and is a chronic progressive mental degenerative disease. [0003] The chemical name of memantine hydrochloride is 1-amino-3,5-dimethylamantadine hydrochloride. Its structural formula is: [0004] [0005] There is no conjugated double bon...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 刘俊华杨伟涵马萍邓晓云王德刚杜青波
Owner ZHUHAI UNITED LAB
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