Method for determining peramivir intermediate isomers by using high performance liquid chromatography

A high-performance liquid chromatography and intermediate technology, which is applied in the field of high-performance liquid chromatography for determining the isomers of peramivir intermediates, can solve the problems such as the effective analysis of peramivir intermediates that is not disclosed by high-performance liquid chromatography, Achieve high separation, improve quality, and ensure the effect of drug safety

Active Publication Date: 2020-11-24
苏州正济药业有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0015] The invention provides a method for measuring the isomers of peramivir intermediates with high performance liquid chromatography (HPLC), the purpose of which is to solve the problem of effectively analyzing the peramivir intermediates in the prior art without disclosure of high performance liquid chromatography The problem with its isomer approach

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  • Method for determining peramivir intermediate isomers by using high performance liquid chromatography
  • Method for determining peramivir intermediate isomers by using high performance liquid chromatography
  • Method for determining peramivir intermediate isomers by using high performance liquid chromatography

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Embodiment

[0052] Embodiment: a kind of method for the determination of peramivir intermediate isomers with high performance liquid chromatography

[0053] In order to describe the following examples more clearly and concisely, the compounds involved in the examples are represented by codes.

[0054] Peramivir intermediate, namely formula (1):

[0055] (1);

[0056] Impurity A is the enantiomer of peramivir intermediate, namely formula (2):

[0057] (2);

[0058] Impurity B is the structural isomer 1 of the peramivir intermediate, namely formula (3):

[0059] (3);

[0060] Impurity C is the structural isomer 2 of the peramivir intermediate, namely formula (4):

[0061] (4).

[0062] Instrument and parameter settings:

[0063] High performance liquid chromatography: Agilent 1260 high performance liquid chromatography, VWD detector (ultraviolet detector);

[0064] Chromatographic column: normal phase polysaccharide derivative coated chiral chromatographic column, 4.6×250 mm, ...

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Abstract

The invention relates to a method for determining peramivir intermediate isomers by using high performance liquid chromatography. The method is characterized in that an adopted chromatographic columnis a polysaccharide derivative coated chiral chromatographic column; the adopted mobile phase is a mixed solution of isopropanol and normal hexane, and isocratic elution is adopted in a high performance liquid chromatography system; in the mobile phase, the volume ratio of isopropanol to normal hexane is 10: 90 to 20: 80; the flow velocity of the mobile phase is 0.8 to 1.0 ml/min; an adopted detector is an ultraviolet detector, and the monitoring wavelength is 215 nm. The method overcomes the defects in the prior art, solves the problem of analytical determination of the peramivir intermediateisomer, can effectively control the contents of the target product and isomer impurities thereof, avoids the interference of the isomer impurities on the subsequent synthesis reaction, enhances the quality of the subsequent prepared peramivir, and ensures the medication safety. The invention provides an accurate and efficient detection method for determining the isomer of the peramivir intermediate.

Description

technical field [0001] The invention belongs to the field of pharmaceutical analytical chemistry, in particular to a method for determining isomers of peramivir intermediates by high performance liquid chromatography. Background technique [0002] Peramivir is a new type of anti-influenza virus drug, which is a neuraminidase inhibitor. Existing clinical trials have shown that peramivir is effective against influenza A and B. Peramivir was designed and discovered by scientists from BioCryst Pharmaceuticals in the United States through structure-based design and medicinal chemistry. The R&D team is led by Dr. Y.S.Babu. The drug's molecular structure and chemical substances were first published in September 2000 in the Journal of Medicinal Chemistry. Before it was named peramivir, it was called BCX-1812. In January 2009, peramivir was approved by the US Food and Drug Administration to enter the fast track of research and development, and its injection was approved in emergen...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/16G01N30/24G01N30/86
CPCG01N30/02G01N30/06G01N30/16G01N30/24G01N30/8675G01N2030/047
Inventor 李园园
Owner 苏州正济药业有限公司
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