Detection method for related substances in memantine hydrochloride preparation

Abstract

The present invention relates to a detection method for related substances in a memantine hydrochloride preparation, wherein particularly a gas chromatography method is adopted to detect the related substances. Memantine hydrochloride has a stable structure and does not have chromophore, such that memantine hydrochloride is difficultly detected by using an ultraviolet detector. According to the present invention, the disadvantage of memantine hydrochloride is overcome, and defects of poor separation capability of the TLC method and emission of a lot of harmful waste gas of the evaporative light-scattering method are overcome; and the detection method has characteristics of accuracy, convenient operation, good reproducibility and high sensitivity, can completely meet requirements of determination on the related substance impurities, can be provided for controlling special impurities in samples and ensuring product quality, and is suitable for industrial production application.

Description

technical field

[0001] The invention relates to a method for detecting related substances of memantine hydrochloride preparations, belonging to the field of analysis and detection of pharmaceutical preparations. Background technique

[0002] Memantine hydrochloride is N - Methyl-D-aspartate (NMDA) receptor antagonists, mainly used in 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. The drug is a non-competitive, medium-strength and fast voltage-gated NMDA receptor antagonist, which can prevent the overload of intracellular calcium and inhibit the excitotoxicity of excitatory amino acids, and has a good effect on vascular dementia and Alzheimer's dementia. curative effect. Because memantine hydrochloride may introduce residual raw ...

Examples

Embodiment 1

[0026] Embodiment 1: Determination of related substances in memantine hydrochloride oral solution

[0027] Take an appropriate amount (approximately equivalent to 10mg of memantine hydrochloride), put it on a water bath and steam to about 1ml, add an appropriate amount of water and transfer it to a 10ml stoppered test tube, add 1ml of 5mol / L sodium hydroxide solution, shake well, add 1ml of chloroform precisely, Vortex and shake for 5 minutes, let stand for 5 minutes, and separate the chloroform layer as the test solution. Under the following selected chromatographic conditions: (Agilent 6820 gas chromatograph, Cerity QA / QC chromatographic workstation), capillary column with polydimethylsiloxane as stationary phase, hydrogen flame ionization detector, programmed temperature, at Hold at 150°C for 5 minutes, increase to 260°C at a rate of 5°C per minute, and hold for 35 minutes. The detector temperature was 300°C and the injection port temperature was 240°C. The number of ...

Embodiment 2

[0033] Embodiment 2: the mensuration of related substance of memantine hydrochloride tablet

[0034] Take an appropriate amount of this product, grind it finely, accurately weigh the fine powder (approximately equivalent to 10mg of memantine hydrochloride), put it in a 10ml stoppered test tube, add 1ml of water to dissolve, add 1ml of 5mol / L sodium hydroxide solution, shake well, and add chloroform precisely 1ml, vortex and shake for 5 minutes, let it stand for 5 minutes, and separate the chloroform layer as the test solution. Under the following selected chromatographic conditions: (Agilent 6820 gas chromatograph, Cerity QA / QC chromatographic workstation), capillary column with polydimethylsiloxane as stationary phase, hydrogen flame ionization detector, programmed temperature, at Hold at 150°C for 5 minutes, increase to 260°C at a rate of 5°C per minute, and hold for 35 minutes. The detector temperature was 300°C and the injection port temperature was 240°C. The number...

Embodiment 3

[0038] Embodiment 3: Determination of related substances of memantine hydrochloride capsules

[0039]Take an appropriate amount of the content of this product, grind it finely, accurately weigh the fine powder (approximately equivalent to 10mg of memantine hydrochloride), put it in a 10ml stoppered test tube, add 1ml of water to dissolve, add 1ml of 5mol / L sodium hydroxide solution, shake well, and accurately Add 1ml of chloroform, vortex and mix for 5 minutes, let stand for 5 minutes, and separate the chloroform layer as the test solution. Under the following selected chromatographic conditions: (Agilent 6820 gas chromatograph, Cerity QA / QC chromatographic workstation), capillary column with polydimethylsiloxane as stationary phase, hydrogen flame ionization detector, programmed temperature, at Hold at 150°C for 5 minutes, increase to 260°C at a rate of 5°C per minute, and hold for 35 minutes. The detector temperature was 300°C and the injection port temperature was 240°C. ...

technical field

[0001] The invention relates to a method for detecting related substances of memantine hydrochloride preparations, belonging to the field of analysis and detection of pharmaceutical preparations. Background technique

[0002] Memantine hydrochloride is N - Methyl-D-aspartate (NMDA) receptor antagonists, mainly used in 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. The drug is a non-competitive, medium-strength and fast voltage-gated NMDA receptor antagonist, which can prevent the overload of intracellular calcium and inhibit the excitotoxicity of excitatory amino acids, and has a good effect on vascular dementia and Alzheimer's dementia. curative effect. Because memantine hydrochloride may introduce residual raw ...

Examples

Embodiment 1

[0026] Embodiment 1: Determination of related substances in memantine hydrochloride oral solution

[0027] Take an appropriate amount (approximately equivalent to 10mg of memantine hydrochloride), put it on a water bath and steam to about 1ml, add an appropriate amount of water and transfer it to a 10ml stoppered test tube, add 1ml of 5mol / L sodium hydroxide solution, shake well, add 1ml of chloroform precisely, Vortex and shake for 5 minutes, let stand for 5 minutes, and separate the chloroform layer as the test solution. Under the following selected chromatographic conditions: (Agilent 6820 gas chromatograph, Cerity QA / QC chromatographic workstation), capillary column with polydimethylsiloxane as stationary phase, hydrogen flame ionization detector, programmed temperature, at Hold at 150°C for 5 minutes, increase to 260°C at a rate of 5°C per minute, and hold for 35 minutes. The detector temperature was 300°C and the injection port temperature was 240°C. The number of ...

Embodiment 2

[0033] Embodiment 2: the mensuration of related substance of memantine hydrochloride tablet

[0034] Take an appropriate amount of this product, grind it finely, accurately weigh the fine powder (approximately equivalent to 10mg of memantine hydrochloride), put it in a 10ml stoppered test tube, add 1ml of water to dissolve, add 1ml of 5mol / L sodium hydroxide solution, shake well, and add chloroform precisely 1ml, vortex and shake for 5 minutes, let it stand for 5 minutes, and separate the chloroform layer as the test solution. Under the following selected chromatographic conditions: (Agilent 6820 gas chromatograph, Cerity QA / QC chromatographic workstation), capillary column with polydimethylsiloxane as stationary phase, hydrogen flame ionization detector, programmed temperature, at Hold at 150°C for 5 minutes, increase to 260°C at a rate of 5°C per minute, and hold for 35 minutes. The detector temperature was 300°C and the injection port temperature was 240°C. The number...

Embodiment 3

[0038] Embodiment 3: Determination of related substances of memantine hydrochloride capsules

[0039]Take an appropriate amount of the content of this product, grind it finely, accurately weigh the fine powder (approximately equivalent to 10mg of memantine hydrochloride), put it in a 10ml stoppered test tube, add 1ml of water to dissolve, add 1ml of 5mol / L sodium hydroxide solution, shake well, and accurately Add 1ml of chloroform, vortex and mix for 5 minutes, let stand for 5 minutes, and separate the chloroform layer as the test solution. Under the following selected chromatographic conditions: (Agilent 6820 gas chromatograph, Cerity QA / QC chromatographic workstation), capillary column with polydimethylsiloxane as stationary phase, hydrogen flame ionization detector, programmed temperature, at Hold at 150°C for 5 minutes, increase to 260°C at a rate of 5°C per minute, and hold for 35 minutes. The detector temperature was 300°C and the injection port temperature was 240°C. ...

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