Unlock instant, AI-driven research and patent intelligence for your innovation.

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 difficult detection and low detection sensitivity, and achieve the effects of strong practicability, high sensitivity, and simple operation

Active Publication Date: 2009-10-07
SHANDONG INST OF PHARMA IND
View PDF5 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • 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, 717Plus 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 filler (4.6mmX250mm, 5μm), referring to...

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

[0035] Embodiment three: the mensuration of the dissolution rate of memantine hydrochloride capsule

[0036]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...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
recovery rateaaaaaaaaaa
Login to View More

Abstract

The invention discloses a method for detecting the dissolution rate of memantine hydrochloride-related preparations. Specifically, a high-performance liquid chromatograph-evaporative light scattering detector is used, and methanol-0.05% pentafluoropropionic acid solution is used as the mobile phase. Take 6 units of memantine hydrochloride-related preparations, use 100ml of 0.1mol / L hydrochloric acid solution as solvent, and after 30 minutes, take an appropriate amount of the solution and filter it as the test solution. Take another reference substance and add water to make a 0.1mg / ml solution as the reference substance solution. Take 20 μl of each of the two solutions, inject them into the liquid chromatograph, and record the chromatograms. The dissolution rate of memantine hydrochloride was calculated by the peak area according to the external standard method. The invention overcomes the disadvantages that memantine hydrochloride is relatively stable in structure and difficult to detect effectively without absorption in the ultraviolet region, and can accurately detect the dissolution rate of memantine hydrochloride in its related preparations using simple mobile phase conditions, which is simple and fast , Accurate advantages.

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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Patents(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