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Method for detecting dissolution of memantine hydrochloride related preparations

A memantine hydrochloride and detection method technology, which is applied in the field of dissolution detection of memantine hydrochloride-related preparations, can solve the problems of low detection sensitivity and difficult detection, and achieve the effects of high sensitivity, strong practicability and accurate detection methods

Active Publication Date: 2007-09-12
SHANDONG INST OF PHARMA IND
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Since the structure of memantine hydrochloride raw material is relatively stable and has no chromophore, it is difficult to carry out effective detection in the ultraviolet-visible light region
The memantine hydrochloride test sample was dissolved and formulated into a solution containing 5.0mg per 1ml, and the detection wavelength of 205nm was selected, but the detection sensitivity was still low

Method used

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  • Method for detecting dissolution of memantine hydrochloride related preparations
  • Method for detecting dissolution of memantine hydrochloride related preparations
  • Method for detecting dissolution of memantine hydrochloride related preparations

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] 1. Chromatographic conditions and system suitability test:

[0020] 1.1. Selection of detection instruments: Since the structure of this product is relatively stable and there is no chromophore, this product has no absorption in the ultraviolet region. Dissolve the memantine hydrochloride test sample with methanol and prepare a solution containing 5.0mg per 1ml, and select the detection wavelength of 205nm, the detection sensitivity is still low, therefore, in order to better detect impurities and better control product quality , we chose an evaporative light scattering detector.

[0021] 1.2. Selection of chromatographic conditions:

[0022] Instruments: SHIMADZU LC-10AT VP, Alltech ELSD 2000, 717 Plus Auto sampler. The temperature range of the ELSD drift tube is 70-130°C, and the optimum detection temperature is 100°C; the nitrogen flow rate is 2.0-2.5L / min. The liquid chromatographic column uses octadecyl bonded silica gel as a filler (4.6mm×250mm, 5μm). Referring...

Embodiment 2

[0031] Embodiment two: the mensuration of memantine hydrochloride tablet dissolution rate

[0032] Get three batches of each six tablets of this product, according to the dissolution assay method (Chinese Pharmacopoeia 2000 edition two appendix XC third method), with 0.1mol / L hydrochloric acid solution 100ml as solvent, rotating speed is 75 revolutions per minute, operate according to law, through In 30 minutes, take an appropriate amount of the solution, filter, and get the subsequent filtrate as the test solution. In addition, an appropriate amount of memantine hydrochloride reference substance was accurately weighed, and a solution containing about 0.1 mg of memantine hydrochloride per 1 ml was made by the same method as the reference substance solution. Under the following selected chromatographic conditions: HPLC-ELSD detector (SHIMADZU LC-10AT VP, Alltech ELSD 2000, 717 Plus Auto sampler), using octadecylsilane bonded silica gel as filler, methanol-0.05% five Fluoroprop...

Embodiment 3

[0034] Embodiment three: the mensuration of the dissolution rate of memantine hydrochloride capsule

[0035]Get three batches of each six capsules of this product, according to the dissolution assay method (Chinese Pharmacopoeia version two in 2000 appendix XC third method), with 0.1mol / L hydrochloric acid solution 100ml as solvent, rotating speed is 75 revolutions per minute, operate according to law, through In 30 minutes, take an appropriate amount of the solution, filter, and get the subsequent filtrate as the test solution. In addition, an appropriate amount of memantine hydrochloride reference substance was accurately weighed, and a solution containing about 0.1 mg of memantine hydrochloride per 1 ml was made by the same method as the reference substance solution. Under the following selected chromatographic conditions: HPLC-ELSD detector (SHIMADZU LC-10AT VP, Alltech ELSD 2000, 717 Plus Auto sampler), using octadecylsilane bonded silica gel as filler, methanol-0.05% fiv...

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Abstract

This invention relates to a dissolution test method of hydrochloric acid memantine correlation preparation. The invention adopts high performance liquid chromatograph - evaporation light scattering detector, takes methanol - 0.05 percent penta- fluorine propanoic acid solution as mobile phase. The invention gets memantine correlation preparation six unit, and take 0.1 mol / L hydrochloric acid solution 100 ml as solvent, by 30 minutes, then take right amount solution to filter out as examining solution. Add water into controlling article to prepare 0.1 mg / ml solution for controlling article solution. Taking each kind solution 20 mu L to inject to liquid phase chromatograph, recording chromatogram. By external standard method and peak area to calculate dissolution degree of hydrochloric acid memantine. This invention overcome the shortcoming of that hydrochloric acid memantine structure is more stable and can not carry out effective detection without absorbing at ultraviolet region. The invention can just use simple mobile phase condition to accuracy detect hydrochloric acid memantine dissolution of correlation preparation, possess quickly and precise merit.

Description

technical field [0001] The invention relates to a method for detecting the dissolution rate of memantine hydrochloride-related preparations, belonging to the field of analysis and detection of pharmaceutical preparations. Background technique [0002] Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist, which is mainly used for the treatment of Alzheimer's disease (senile dementia) by delaying the release of excitatory neurotransmitter glutamate ). Alzheimer's disease is one of the common diseases of the elderly, mainly manifested as memory loss and cognitive impairment, and is a progressive neurodegenerative disorder. This product is currently the only NMDA antagonist developed for Alzheimer's disease. Since the structure of the memantine hydrochloride bulk drug is relatively stable and has no chromophore, it is difficult to carry out effective detection in the ultraviolet-visible light region. The memantine hydrochloride test sample was dissolv...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N33/15
Inventor 张岱州李玉基王功霞梁大连朱春花
Owner SHANDONG INST OF PHARMA IND
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