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Method for separating and determining memantine starting material and related substances by using gas chromatography

A technology for gas chromatography and related substances, which is applied in the field of separation and determination of memantine hydrochloride starting materials and related substances by gas chromatography, can solve the problems of incomplete removal of impurities, influence on the purity and quality of medicines, etc., and achieves a low yield. Effect

Inactive Publication Date: 2021-07-16
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] Incomplete removal of impurities in the starting material of memantine hydrochloride will affect the purity and quality of the drug

Method used

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  • Method for separating and determining memantine starting material and related substances by using gas chromatography
  • Method for separating and determining memantine starting material and related substances by using gas chromatography
  • Method for separating and determining memantine starting material and related substances by using gas chromatography

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Instruments and Conditions

[0042] Chromatograph: Agilent 6890N gas chromatograph;

[0043] Detector: hydrogen flame ionization detector;

[0044] Chromatographic column: DB-1 capillary column (Agilent, 30m´0.32mm, 1.5μm);

[0045] Column temperature: initial temperature 80°C, constant temperature 5min, to 200°C at a heating rate of 5°C per minute, constant temperature 5min;

[0046] Injection port temperature: 250°C;

[0047] Detector temperature: 280°C;

[0048] Carrier gas (nitrogen) flow rate: 1.0mL / min;

[0049] Split ratio: 50:1;

[0050] Injection volume: 1μL

[0051] Experimental procedure

[0052] Take 100mg~200mg of the starting material of memantine hydrochloride, dissolve it with a solvent, and prepare a test solution containing 20~40mg of the starting material of memantine hydrochloride per 1mL; take appropriate amount of each related substance, dissolve it with a solvent, Prepare a related substance stock solution containing 1.0~2.0mg of each rela...

Embodiment 2

[0054] Instruments and Conditions

[0055] Chromatographic column: DB-1 capillary column (Agilent, 30m´0.32mm, 1.5μm);

[0056] Column temperature: initial temperature of 40°C, constant temperature for 5min, to 150°C at a heating rate of 10°C per minute, constant temperature for 8min;

[0057] Injection port temperature: 250°C;

[0058] Detector temperature: 280°C;

[0059] Carrier gas (nitrogen) flow rate: 1.1mL / min;

[0060]Split ratio: 50:1;

[0061] Injection volume: 1μL

[0062] Experimental procedure

[0063] Take an appropriate amount of each related substance, dissolve it with a solvent, and prepare a related substance stock solution containing 1.0~2.0mg of each related substance per 1mL; take another 100mg~200mg of memantine hydrochloride starting material, add 0.1mL of each related substance stock solution , dissolve it with a solvent, shake well, and prepare a system suitability solution containing 0.02~0.04mg of each related substance per 1mL. Analyze accord...

Embodiment 3

[0065] Instruments and Conditions

[0066] Chromatographic column: DB-1 capillary column (Agilent, 30m´0.32mm, 1.5μm);

[0067] Column temperature: initial temperature of 40°C, constant temperature for 5min, to 150°C at a heating rate of 10°C per minute, constant temperature for 8min;

[0068] Injection port temperature: 250°C;

[0069] Detector temperature: 280°C;

[0070] Carrier gas (nitrogen) flow rate: 0.9mL / min;

[0071] Split ratio: 50:1;

[0072] Injection volume: 1μL

[0073] Experimental procedure

[0074] Take an appropriate amount of each related substance, dissolve it with a solvent, and prepare a related substance stock solution containing 1.0~2.0mg of each related substance per 1mL; take another 100mg~200mg of memantine hydrochloride starting material, add 0.1mL of each related substance stock solution , dissolve it with a solvent, shake well, and prepare a system suitability solution containing 0.02~0.04mg of each related substance per 1mL. Analyze accor...

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Abstract

The invention belongs to the field of analytical chemistry, and discloses a method for separating and determining a memantine hydrochloride starting material 1, 3-Dimethylaminamantine and related substances thereof by using a gas chromatography. The method adopts a capillary chromatographic column filled with 100% dimethyl polysiloxane anda hydrogen flame ionization detector, and canquantitatively determine the content of the memantine hydrochloride starting material and the related substances thereof, so that the purity of reactants in the process of synthesizing memantine hydrochloride is effectively controlled, side reactions and impurities are reduced, and the product yield is improved. The method is high in specificity, high in accuracy and simple and convenient to operate.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a method for separating and measuring memantine hydrochloride starting materials and related substances by gas chromatography. Background technique [0002] Memantine hydrochloride is a voltage-dependent, moderate-affinity, non-competitive glutamate receptor antagonist, which can block neuronal damage caused by pathologically elevated glutamate concentrations, and is mainly used for moderate to severe Alzheimer's disease patients with schizophrenia. The chemical name of memantine hydrochloride is 1-Amino-3,5-dimethyladamantane hydrochloride, and its molecular formula is C 12 h 21 N·HCl. The chemical name of the starting material of memantine hydrochloride is 1,3-Dimethyladamantane, and the molecular formula is C 12 h 20 , the structural formula is: [0003] [0004] In the process of synthesizing memantine hydrochloride, it is necessary to control the puri...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/60
CPCG01N30/02G01N30/60
Inventor 丁欣刘秋叶张力娜
Owner BEIJING VENTUREPHARM BIOTECH
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