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Separation and determination method of apremilast and potential genotoxic impurities thereof

A genotoxic and potential technology, applied in the field of analytical chemistry, can solve the problems of no separation and determination of apremilast and its potential genotoxic impurities, and achieve the effects of effective control of impurities, simple operation, and product quality assurance

Active Publication Date: 2017-08-04
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, there is currently no HPLC method for the separation and determination of apremilast and its potential genotoxic impurities

Method used

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  • Separation and determination method of apremilast and potential genotoxic impurities thereof
  • Separation and determination method of apremilast and potential genotoxic impurities thereof
  • Separation and determination method of apremilast and potential genotoxic impurities thereof

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Embodiment

[0044] The instrument and chromatographic conditions adopted in the present embodiment are as follows:

[0045] Instrument: SHIMADZU LC-2010AHT;

[0046] Chromatographic column: Agilent ZORBAX SB-C18 (4.6×250mm, 5μm);

[0047] Mobile phase: acetonitrile: 0.1% phosphoric acid aqueous solution = 48:52 (V:V);

[0048] Wavelength: 230nm;

[0049] Column temperature: 30°C;

[0050] Flow rate: 1.0ml / min;

[0051] Injection volume: 20μl;

[0052] Diluent: Acetonitrile.

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Abstract

The invention belongs to the field of analytic chemistry, and concretely relates to a separation and determination method of apremilast and potential genotoxic impurities thereof. The method comprises the steps of adopting a chromatographic column taking octadecyl silane bonded silica gel as filler, and concretely comprises the steps of adding a diluting agent for dissolving each potential genotoxic impurity reference substance so as to prepare a reference substance solution with known concentration; adding a diluting agent for dissolving a sample for test so as to prepare a solution of the sample for test; taking the reference substance solution and the solution of the sample for test respectively for sample injection; adopting a moving phase for carrying out high performance liquid chromatography elution analysis, and recording a chromatogram map; comparing peak areas of impurities, corresponding to peak appearance times, in the reference substance solution and the solution of the sample for test, and calculating the contents of the apremilast and the potential genotoxic impurities contained in the sample for test. The method is high in specificity, high in sensitivity (the limit of detection of the potential genotoxic impurities of SM1 is 0.0004 percent), and simple to operate, and has the advantages of convenience and quickness.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a separation and determination method of apremilast and its potential genotoxic impurities. Background technique [0002] Apremilast is a phosphodiesterase PDE4 inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The Chinese name of Apremilast is: (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoind Indoline-1,3-dione, English name: (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methanesulfonylethyl]-4-acetyl-aminoisoindoline-1,3-dione, Its structural formula is shown in formula II: [0003] [0004] Genotoxic impurities refer to substances that can directly or indirectly damage cell DNA and produce mutagenic and carcinogenic effects. Genotoxic reactants and substances with genotoxic structures that do not appear in active pharmaceutical substances are called potential genotoxic i...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 周春燕杨静曾正英
Owner CHONGQING HUAPONT PHARMA
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