A kind of method for determining peramivir intermediate isomer by high performance liquid chromatography

A technology of high performance liquid chromatography and intermediates, applied in the field of isomer determination of peramivir intermediates by high performance liquid chromatography, can solve the problems of effective analysis of peramivir intermediates by high performance liquid chromatography, etc. Achieve the effects of good specificity, symmetrical peak shape, and quality improvement

Active Publication Date: 2022-08-05
苏州正济药业有限公司
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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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  • A kind of method for determining peramivir intermediate isomer by high performance liquid chromatography
  • A kind of method for determining peramivir intermediate isomer by high performance liquid chromatography
  • A kind of method for determining peramivir intermediate isomer by high performance liquid chromatography

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Embodiment

[0052] Embodiment: a kind of method of measuring peramivir intermediate isomer 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 symbols.

[0054] Peramivir intermediate, that is, formula (1):

[0055] (1);

[0056] Impurity A is the enantiomer of the peramivir intermediate, that is, 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 chromatograph: Agilent 1260 high performance liquid chromatograph, VWD detector (ultraviolet detector);

[0064] Chromatographic column: normal-phase polysaccharide derivative-coated chiral column, 4.6×250 mm, 5 µm;

[0065] Mobil...

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Abstract

A method for determining peramivir intermediate isomers by high performance liquid chromatography, characterized in that: the adopted chromatographic column is a polysaccharide derivative-coated chiral chromatographic column; the adopted mobile phase is isopropanol and n-hexane The mixed solution of alkane is eluted by isocratic in the high performance liquid chromatography system; in the mobile phase, the volume ratio of isopropanol and n-hexane is 10:90~20:80; the flow rate of the mobile phase is 0.8 ~1.0 ml / min; the detector used is an ultraviolet detector with a monitoring wavelength of 215 nm. The invention overcomes the deficiencies of the prior art, solves the problem of analysis and determination of peramivir intermediate isomers, can effectively control the impurity content of the target product and its isomers, and avoids the interference of isomer impurities on subsequent synthesis reactions , improve the quality of the subsequent preparation of peramivir, and ensure the safety of medication. The invention provides an accurate and efficient detection method for the isomer determination of peramivir intermediates.

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, a neuraminidase inhibitor. Existing clinical trials have shown that peramivir is effective against influenza A and B. Peramivir was designed and discovered by scientists at BioCryst Pharmaceuticals in the United States through structure-based design and medicinal chemistry methods. The R&D team is led by Dr. Y.S.Babu. The drug's molecular structure and chemistry were first published in the September 2000 issue of the Journal of Medicinal Chemistry. Before being named peramivir, it was called BCX-1812. In January 2009, peramivir was granted Fast Track approval by the U.S. Food and Drug Administration for its injection and was approved in emergency situations for the treatment...

Claims

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Application Information

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Patent Type & Authority Patents(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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