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Method for detecting (R)-1-(1-naphthyl)ethylamine chiral isomer

A technology for chiral isomers and ethylamine, applied in the field of drug analysis, can solve problems such as undiscovered, and achieve the effect of simple and convenient high-performance liquid phase detection method

Inactive Publication Date: 2018-04-27
ENANTIOTECH CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] At present, there are no related reports on isomers and chiral purity detection methods of (R)-1-(1-naphthyl)ethylamine, in order to strengthen the identification of (R)-1-(1-naphthyl)ethylamine Quality control, to better control the efficacy of the prepared cinacalcet, it is necessary to develop a simple, accurate, fast, reliable, stable (R)-1-(1-naphthyl)ethylamine chiral isotropic High Performance Liquid Chromatography

Method used

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  • Method for detecting (R)-1-(1-naphthyl)ethylamine chiral isomer

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Embodiment 1

[0029] A method for detecting (R)-1-(1-naphthyl)ethylamine chiral isomers, comprising the following steps:

[0030] 1) Preparation of system suitability solution: Weigh appropriate amounts of (R)-1-(1-naphthyl)ethylamine and (S)-1-(1-naphthyl)ethylamine respectively, and place them in the same volumetric flask. Add 1ml of ethanol to dissolve, and then use the mobile phase solution to prepare a solution containing 0.5mg of (R)-1-(1-naphthyl)ethylamine and (S)-1-(1-naphthyl)ethylamine per ml , to obtain the system suitability solution;

[0031] 2) Preparation of the test solution: take an appropriate amount of the test solution, add 1ml of ethanol to dissolve, then use the mobile phase solution to prepare a solution with a concentration of 1mg / ml, and add it to the test solution;

[0032] 3) Sample injection: inject the system suitability solution and the test solution into the high performance liquid chromatograph respectively, measure according to the set high performance liq...

Embodiment 2

[0039] A method for detecting (R)-1-(1-naphthyl)ethylamine chiral isomers, comprising the following steps:

[0040] 1) Preparation of system suitability solution: Weigh appropriate amounts of (R)-1-(1-naphthyl)ethylamine and (S)-1-(1-naphthyl)ethylamine respectively, and place them in the same volumetric flask. Add 1ml of ethanol to dissolve, and then use the mobile phase solution to prepare a solution containing 0.5mg of (R)-1-(1-naphthyl)ethylamine and (S)-1-(1-naphthyl)ethylamine per ml , to obtain the system suitability solution;

[0041] 2) Preparation of the test solution: take an appropriate amount of the test solution, add 1ml of ethanol to dissolve, then use the mobile phase solution to prepare a solution with a concentration of 1mg / ml, and add it to the test solution;

[0042]3) Sample injection: inject the system suitability solution and the test solution into the high performance liquid chromatograph respectively, measure according to the set high performance liqu...

Embodiment 3

[0047] A method for detecting (R)-1-(1-naphthyl)ethylamine chiral isomers, comprising the following steps:

[0048] 1) Preparation of system suitability solution: Weigh appropriate amounts of (R)-1-(1-naphthyl)ethylamine and (S)-1-(1-naphthyl)ethylamine respectively, and place them in the same volumetric flask. Add 1mL of ethanol to dissolve, and then use the mobile phase solution to prepare a solution containing 0.5mg of (R)-1-(1-naphthyl)ethylamine and (S)-1-(1-naphthyl)ethylamine per ml , to obtain the system suitability solution;

[0049] 2) Preparation of the test product solution: take an appropriate amount of the test product, add 1 mL of ethanol to dissolve, then use the mobile phase solution to prepare a solution with a concentration of 1 mg / mL, and add it to the test product solution;

[0050] 3) Sample injection: inject the system suitability solution and the test solution into the high performance liquid chromatograph respectively, measure according to the set hig...

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Abstract

The invention discloses a method for detecting a (R)-1-(1-naphthyl)ethylamine chiral isomer. According to the invention, a chiralcelOD-H chromatographic column is taken as a chiral chromatographic column, an area normalization method is employed for calculating content of the chiral isomer in a tested object solution, the high performance liquid chromatography condition is characterized in that the temperature of the chromatographic column is 36-43 DEG C, mixed liquor of hexane, isopropanol, ethanol, diethylamine and trifluoroacetic acid is taken as a mobile phase, the flow velocity of the mobile phase is 0.7-1.5 mL / min, a sample size is 15-23 [mu]L, a ultraviolet detector is employed, and a detection wavelength is set as 260-290 nm. The high-efficiency liquid-phase detection method is simple, accurate, rapid, reliable and stable, can accurately detect the content of the (R)-1-(1-naphthyl)ethylamine chiral isomer, and the mass of the (R)-1-(1-naphthyl)ethylamine as well as the efficacyof prepared cinacalcet can be better controlled.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and relates to a method for detecting chiral isomers of (R)-1-(1-naphthyl)ethylamine, more specifically to detecting (R)-1-(1 -A method for the chiral purity, isomer content, and EE value of -naphthyl)ethylamine. Background technique [0002] (R)-1-(1-naphthyl)ethylamine is an important intermediate in the production of cinacalcet, and its chiral purity, isomer content, and EE value directly affect the chiral purity and isomerization of cinacalcet. body content, EE value, and the chiral purity of cinacalcet directly affects the curative effect of the drug, so the chiral purity and isomer content of (R)-1-(1-naphthyl)ethylamine are detected for controlling (R) )-1-(1-naphthyl)ethylamine is very traditional in quality. The chemical formula of (R)-1-(1-naphthyl)ethylamine is formula I: [0003] [0004] High-performance liquid chromatography uses liquid as the mobile phase, and uses a hi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 蒙发明曹欢燕徐亮
Owner ENANTIOTECH CORP
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