HPLC-ELSD measuring method for correlated matter in memantine hydrochloride

A technology of memantine hydrochloride and related substances, which is applied in the field of analysis and detection of pharmaceutical preparations, can solve the problems of low detection sensitivity, no chromophore, and difficult detection, and achieve the effects of high sensitivity, improved detection sensitivity, and strong practicability

Active Publication Date: 2007-09-19
SHANDONG INST OF PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since memantine hydrochloride may introduce residual raw materials and other related substances during the synthesis process, and may also produce degradation products during storage, and the structure of this raw material drug is relatively stable, without chromophoric groups, it is difficult to carry out effective production in the ultraviolet-visible light region. detection
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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  • HPLC-ELSD measuring method for correlated matter in memantine hydrochloride
  • HPLC-ELSD measuring method for correlated matter in memantine hydrochloride
  • HPLC-ELSD measuring method for correlated matter in memantine hydrochloride

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] 1. Chromatographic conditions and system suitability test:

[0022] 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.

[0023] 1.2. Selection of chromatographic conditions:

[0024] 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

[0035] Embodiment two: the mensuration of related substance of memantine hydrochloride tablet

[0036] Take an appropriate amount of this product, grind it finely, precisely weigh the fine powder (approximately equivalent to 30 mg of memantine hydrochloride), add mobile phase to prepare a solution containing 0.3 mg per 1 ml, filter, and take the filtrate as the test solution. Precisely measure an appropriate amount, add mobile phase to dilute to a solution containing about 6 μg per 1 ml, and use it as a control 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-acetonitrile-iso Propanol-water (50:20:20:10) was used as the mobile phase, and triethylamine solution was added dropwise in the mobile phase to adjust the pH value to 7.8, the column temperature was room temperature, and the flow rate was 1.0ml / min. The theoret...

Embodiment 3

[0038] Embodiment Three: Determination of Related Substances in Memantine Hydrochloride Capsules

[0039]Take an appropriate amount of the content of this product, grind it finely, precisely weigh the fine powder (approximately equivalent to 30 mg of memantine hydrochloride), add mobile phase to prepare a solution containing 0.3 mg per 1 ml, filter, and take the filtrate as the test solution. Precisely measure an appropriate amount, add mobile phase to dilute to a solution containing about 6 μg per 1 ml, and use it as a control 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-acetonitrile-iso Propanol-water (50:20:20:10) was used as the mobile phase, and triethylamine solution was added dropwise in the mobile phase to adjust the pH value to 7.8, the column temperature was room temperature, and the flow rate was 1.0ml / ...

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Abstract

The present invention discloses a method used for detecting memantine hydrochloride as well as related matters thereof, specifically, a HPLC-ELSD detector is utilized and a methanol-acetonitrile-isopropanol-triethylamine solution is adopted as a mobile phase. The mobile phase is added to an appropriate amount of memantine hydrochloride as well as related preparations containing memantine hydrochloride to prepare a solution containing 0.3 mg memantine hydrochloride per 1 ml acting as a testing solution. The testing solution is then diluted to a concentration of 6 mu g memantine hydrochloride per 1 ml to act as a reference solution, using the mobile phase. The sample is introduced respectively to insure that the peak area sum of a variety of impurities in the testing solution is not more than the main peak area of the reference solution. the method used for detecting memantine hydrochloride as well as related preparations containing memantine hydrochloride in accordance with the present invention overcomes the shortcoming that it is difficult to perform an effective detection due to that the local structure is stable and there is no absorption in the ultraviolet region, and is capable of detecting the impurity in the emantine hydrochloride and conditions of degradation products, quickly and correctly. Said method is capable of better controlling product quality, with simple and convenient operations and high sensitivity.

Description

technical field [0001] The invention relates to a method for detecting related substances of memantine hydrochloride and related preparations containing memantine hydrochloride, 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 memantine hydrochloride may introduce residual raw materials and other related substances during the synthesis process, and may also produce degradation products during storage, and the structure of this r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/15G01N30/02G01N30/88
Inventor 张岱州李玉基梁大连王功霞朱春花
Owner SHANDONG INST OF PHARMA IND
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