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Method for separating and determining lacosamide residual solvent by gas chromatography

A technology of gas chromatography and lacosamide, which is applied in the field of separation and determination of lacosamide residual solvents by gas chromatography, can solve the problems of incomplete removal of residual solvents and affect the safety of medication, and achieve the effect of ensuring safety

Pending Publication Date: 2021-10-19
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Incomplete removal of residual solvents in lacosamide will seriously affect the safety of the drug

Method used

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  • Method for separating and determining lacosamide residual solvent by gas chromatography
  • Method for separating and determining lacosamide residual solvent by gas chromatography
  • Method for separating and determining lacosamide residual solvent by gas chromatography

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Instruments and Conditions

[0041] Chromatograph: Shimadzu 2010 plus gas chromatograph;

[0042] Detector: hydrogen flame ionization detector;

[0043] Chromatographic column: DB-624UI capillary column (Agilent, 30m´0.32mm, 1.8μm);

[0044] Column temperature: initial temperature 50°C, to 70°C with a rate of increase of 5°C per minute, constant temperature for 5min; to 110°C with a rate of increase of temperature of 5°C per minute, to 180°C, constant temperature for 5 minutes.

[0045] Injection port temperature: 230°C;

[0046] Detector temperature: 260°C;

[0047] Carrier gas (nitrogen) flow rate: 1.0mL / min;

[0048] Split ratio: 20:1;

[0049] Injection volume: 1μL

[0050] Experimental procedure

[0051] Take 100mg~200mg of lacosamide, dissolve it with a solvent, and prepare a test solution containing 100~200mg of lacosamide per 1mL; take an appropriate amount of each residual solvent, dissolve it with a solvent, and prepare a solution containing methyl Is...

Embodiment 2

[0053] Instruments and Conditions

[0054] Chromatograph: Shimadzu 2010 plus gas chromatograph;

[0055] Detector: hydrogen flame ionization detector;

[0056] Chromatographic column: DB-624UI capillary column (Agilent, 30m´0.32mm, 1.8μm);

[0057] Column temperature: initial temperature 50°C, to 70°C with a rate of increase of 5°C per minute, constant temperature for 5min; to 110°C with a rate of increase of temperature of 5°C per minute, to 200 ° C, constant temperature 5min.

[0058] Injection port temperature: 230°C;

[0059] Detector temperature: 260°C;

[0060] Carrier gas (nitrogen) flow rate: 1.0mL / min;

[0061] Split ratio: 20:1;

[0062] Injection volume: 1μL

[0063] Experimental procedure

[0064] Take an appropriate amount of each residual solvent, dissolve it with a solvent, and prepare a reference solution containing 500 μg-1000 μg of methyl isobutyl ketone and 495 μg-990 μg of N-methylmorpholine per 1 mL, take 100 mg-200 mg of lacosamide, add Shake 1.0 m...

Embodiment 3

[0066] Instruments and Conditions

[0067] Chromatograph: Shimadzu 2010 plus gas chromatograph;

[0068] Detector: hydrogen flame ionization detector;

[0069] Chromatographic column: DB-624UI capillary column (Agilent, 30m´0.32mm, 1.8μm);

[0070] Column temperature: initial temperature 50°C, to 110°C at a heating rate of 5°C per minute, constant temperature for 3min; to 200°C at a heating rate of 10°C per minute, constant temperature for 5min.

[0071] Injection port temperature: 230°C;

[0072] Detector temperature: 260°C;

[0073] Carrier gas (nitrogen) flow rate: 1.0mL / min;

[0074] Split ratio: 20:1;

[0075] Injection volume: 1μL

[0076] Experimental procedure

[0077] Take an appropriate amount of each residual solvent, dissolve it with a solvent, and prepare a reference solution containing 500μg-1000μg of methyl isobutyl ketone and 495μg-990μg of N-methylmorpholine per 1mL; take another 100mg~200mg of lacosamide, Add 1.0 mL of reference substance solution, sh...

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Abstract

The invention belongs to the field of analytical chemistry, and discloses a method for separating and determining a lacosamide residual solvent by gas chromatography, which adopts 6% cyanopropyl phenyl and 94% dimethyl polysiloxane weak polarity capillary chromatographic column and a hydrogen flame ionization detector to quantitatively determine the content of the lacosamide residual solvent. Therefore, the residual solvent in the lacosamide is effectively controlled, and the quality of the lacosamide is controllable. 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 lacosamide residual solvents by gas chromatography. Background technique [0002] Lacosamide is a novel N-methyl-D-aspartate (NMDA) receptor glycine site-binding antagonist, which belongs to a new class of functional amino acids. Therefore, lacosamide is an anticonvulsant drug with a new dual mechanism of action, which can selectively promote the slow inactivation of sodium channels, and at the same time can regulate the collapse response mediator protein 2 (CRMP-2), and CRMP-2 may slow down or even [0003] Prevents seizures and reduces neuropathic pain in diabetes. Lacosamide chemical name: [0004] (2R)-2-(acetylamino)--N-benzyl-3-methoxy-propanamide, the molecular formula is C 13 h 18 N 2 o 3 . The structural formula is: [0005] In the process of synthesizing lacosamide, residual solvents are introduced, because ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/30G01N30/32G01N30/68G01N30/86G01N30/60G01N30/88
CPCG01N30/02G01N30/06G01N30/30G01N30/32G01N30/68G01N30/8634G01N30/60G01N30/88G01N2030/3084G01N2030/324G01N2030/884
Inventor 贺美艳刘秋叶
Owner BEIJING VENTUREPHARM BIOTECH
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