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Method for detecting milnacipran isomers

A detection method and technology of milnacipran, which is applied in the field of detection of milnacipran isomers, can solve the problem of not finding an efficient, simple and sensitive analytical method, etc.

Active Publication Date: 2020-05-19
CHENGDU KANGHONG PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the literature discloses some methods for the resolution of milnacipran enantiomers, which can be resolved to obtain high-purity levomilnacipran enantiomers. However, an efficient, simple and sensitive analysis method has not been found yet. The method can be used for the content determination of trace milnacipran enantiomers in preparation products

Method used

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  • Method for detecting milnacipran isomers
  • Method for detecting milnacipran isomers
  • Method for detecting milnacipran isomers

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0105] The preparation method of need testing solution is as follows: Accurately take by weighing appropriate amount of contents of self-made milnacipran hydrochloride sustained-release capsules (approximately equivalent to 5 mg of levomilnacipran) and put in a 10ml measuring bottle, add 1ml of ethanol, shake to disperse into independent Add a proper amount of diluent (n-hexane-ethanol=1000:25, v / v) to the pellet, ultrasonically for 30 minutes, let it cool, add diluent (n-hexane-ethanol=1000:25, v / v) to dilute to the mark, Shake well, filter, and take the continued filtrate as the test solution.

[0106] The preparation method of the system suitability solution is as follows: Accurately weigh an appropriate amount of the contents of the self-made milnacipran sustained-release capsules (approximately equivalent to 5 mg of levomilnacipran) and put it in a 10ml measuring bottle, add 1ml of ethanol to oscillate to disperse into independent pellets, Precisely add an appropriate amo...

Embodiment 2

[0113] Test solution: Take a few commercially available milnacipran hydrochloride tablets, grind them finely, mix well, take an appropriate amount of fine powder (approximately equivalent to 25 mg of L-milnacipran) into a 50ml measuring bottle, add 5ml of ethanol to oscillate to disperse , add diluent (n-hexane-ethanol=1000:25, v / v) appropriate amount of ultrasonic treatment for 30min, add diluent (n-hexane-ethanol=1000:25, v / v) to dilute to the mark, shake well, filter, take Continue to obtain the filtrate.

[0114] The preparation method of the system suitability solution is as follows: Accurately weigh an appropriate amount of powder of commercially available milnacipran hydrochloride tablets (approximately equivalent to 5 mg of levomilnacipran) and put it in a 10 ml measuring bottle, add 1 ml of ethanol and oscillate to disperse into independent pellets, and precisely Add an appropriate amount of D-milnacipran reference substance, add an appropriate amount of diluent (n-he...

Embodiment 3

[0120] The preparation method of need testing solution is as follows: Accurately take by weighing commercially available milnacipran hydrochloride sustained-release capsule content (approximately equivalent to L-milnacipran 5mg) put 10ml measuring bottle, add ethanol 1ml, shake to disperse into independent Add a proper amount of diluent (n-hexane-ethanol=1000:25, v / v), ultrasonic for 30 minutes, let cool, add diluent (n-hexane-ethanol=1000:25, v / v) to dilute to the mark , Shake well, filter, and take the continued filtrate as the test solution.

[0121] The preparation method of the system suitability solution is as follows: Accurately weigh an appropriate amount of the content of the commercially available milnacipran hydrochloride sustained-release capsules (approximately equivalent to 5 mg of levomilnacipran) and put it in a 10 ml measuring bottle, add 1 ml of ethanol and oscillate to disperse into independent pellets , precisely add an appropriate amount of D-milnacipran r...

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Abstract

The invention provides a milnacipran isomer detection method. The method adopts a normal phase chromatography method, takes amylose-tri (3, 5-dimethyl phenyl carbamate) silica gel as a chromatographiccolumn filler, takes n-hexane: ethanol: trifluoroacetic acid: diethylamine as mobile phases, and adopts gradient elution. The detection method disclosed by the invention does not need to perform complex pretreatment on a sample to be detected, can effectively separate target components and interference components in crude drugs or pharmaceutical compositions, has advantages of high efficiency, simplicity, convenience and the like, and is suitable for industrial application.

Description

technical field [0001] The invention relates to the field of drug detection, in particular to a method for detecting milnacipran isomers. [0002] technical background [0003] Depression is a mental disease that seriously endangers the physical and mental health of human beings. Taking antidepressant drugs is one of the main methods to treat depression. Milnacipran is a specific dual inhibitor of serotonin and norepinephrine reuptake, which was first launched in France in 1997 for the treatment of severe depression. [0004] The chemical name of milnacipran is 2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide, and its molecule contains two chiral carbon atoms. There are two forms of Nacipran, racemic and levorotatory. Chiral drug enantiomers often present different pharmacological and pharmacodynamic properties in vivo. Studies have shown that L-milnacipran has higher activity in milnacipran enantiomers, and has good safety and human tolerance , Compared with th...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 柯潇周灵利陈维维罗雪
Owner CHENGDU KANGHONG PHARMA GRP
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