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Method for detecting memantine hydrochloride in memantine hydrochloride tablet

A technology of memantine hydrochloride and a detection method, which is applied to measurement devices, instruments, scientific instruments, etc., can solve the problems of complex extraction, expensive instruments, poor reproducibility, etc., and achieves high chromatographic peak separation and high system applicability. Effect

Inactive Publication Date: 2022-05-06
珠海润都制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although memantine is limited to delaying the development of AD or mild improvement, it cannot completely reverse or cure AD, but as the only NMDA receptor antagonist currently available for the treatment of moderate to severe AD, memantine will continue to play an important role in anti-AD
[0003] The currently disclosed detection technology generally uses a gas chromatograph, which has the disadvantages of complex extraction and poor reproducibility. Publication No. CN101034084A discloses the use of high performance liquid chromatography-evaporative light scattering -0.05% pentafluoropropionic acid was used as the mobile phase to carry out the dissolution of memantine hydrochloride in the detector-related preparations. The equipment used was expensive and inconvenient to use, and high-pressure nitrogen or air generated waste gas during the experiment.

Method used

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  • Method for detecting memantine hydrochloride in memantine hydrochloride tablet
  • Method for detecting memantine hydrochloride in memantine hydrochloride tablet
  • Method for detecting memantine hydrochloride in memantine hydrochloride tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] (1) Chromatographic conditions:

[0030] The instrument selects high-performance liquid chromatography equipped with a differential refractive index detector, uses octadecyl-bonded silica gel as the filler, and uses pH6.0 buffer solution-methanol as the mobile phase, with a flow rate of 1.3ml / min; the temperature of the injector: 25 ℃; injection volume: 15µl; column temperature: 45℃; detector temperature: 45℃; running time: 10min; flushing mode: isocratic.

[0031] (2) Preparation of the test solution:

[0032] Take 5 memantine hydrochloride tablets, put them in a 250ml measuring bottle, add 50ml of pH6.0 buffer solution + 0.2%NaCl, let stand for 5min, shake for 5min, then add 150ml of methanol, ultrasonic for 30min to dissolve completely, and cool to room temperature , dilute to the mark with methanol, shake well; centrifuge at 4000 rpm for 10 min, take the supernatant and filter it with a 0.45µm PVDF filter membrane, discard 3ml of the initial filtrate, and take the ...

Embodiment 2

[0046] Embodiment 2 Detection method system applicability test of the present invention

[0047] The RSD of the peak area of ​​the main peak in the first reference substance solution of 5 needles is not more than 2.0%, the recovery rate of the second reference substance solution relative to the first reference substance solution should be 98.0% to 102.0%, and the theoretical column of the main peak of the reference substance solution The number of plates shall not be greater than 1000, and the tailing factor shall not be greater than 2.5.

[0048] After the system is stable, inject 1 needle each of the blank solution and the reference substance solution. The obtained data is shown in the following table:

[0049]

[0050] 5 RSD of the peak area of ​​the main peak of the reference solution: 0.3%; the recovery rate of the second reference solution relative to the first reference solution is 100.3; the theoretical plate number of the main peak of the reference solution is 255...

Embodiment 3

[0051] Embodiment 3 Detection method specificity test of the present invention

[0052] The test product and the reference product have passed the test conditions of strong acid, strong alkali, oxidation, high temperature and high humidity respectively, and the separation between the main peak and the adjacent degradation peak should meet the requirements.

[0053]

[0054] The resolution between the main peak and adjacent degradation peaks under each degradation condition met the requirements.

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Abstract

The invention discloses a method for detecting memantine hydrochloride in memantine hydrochloride tablets, which specifically adopts a high performance liquid chromatograph to be matched with a differential refraction detector, adopts a buffer solution with pH of 6.0 (taking 2ml of diethylamine, adding water, uniformly mixing, and adjusting the pH value to 6.0 with glacial acetic acid)-methanol solution as a mobile phase, and adopts octadecyl bonded silica gel as a filler of a chromatographic column. A proper amount of memantine hydrochloride is taken, a buffer solution with the pH of 6.0, 0.2% NaCl and methanol are added for preparation, a 0.45 m PVDF filter membrane is used for filtration, 3 ml of primary filtrate is discarded, subsequent filtrate is taken to obtain a test solution, the theoretical plate number of a main peak of the reference solution is 2552, and the tailing factor is 1.7. The quantitative detection method for memantine hydrochloride in the memantine hydrochloride tablet overcomes the defects of complex extraction and poor reproducibility in gas phase detection, can quickly and accurately detect the content of memantine hydrochloride, and is simple and convenient to operate and high in sensitivity.

Description

technical field [0001] The invention belongs to the field of technical analysis and detection in pharmaceutical preparations, in particular to a quantitative detection method for memantine hydrochloride in memantine hydrochloride tablets. Background technique [0002] Memantine Hydrochloride is a white crystalline powder with a chemical name of 1-amino-3,5-dimethylamantadine hydrochloride, which mainly treats a progressive development of nervous system with insidious onset Degenerative diseases (that is, Alzheimer's disease, commonly known as senile dementia). In 2002, it was developed and marketed by Germany’s Merz Pharmaceutical Company (Merz). In September 2006, it was launched in China with the name of the drug “Ebeshen”. born. The maximum daily dose taken is 20mg. In order to reduce the occurrence of side effects, in the first 3 weeks of treatment, the dose should be gradually increased by 5mg every week to reach the maintenance dose. Although memantine is limited to...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 刘杰李必禄黄俊鹏
Owner 珠海润都制药股份有限公司