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Analysis method for separating and detecting oseltamivir phosphate intermediate and impurities thereof

A technology of oseltamivir phosphate and analysis method, applied in the field of analytical chemistry, to achieve the effects of short detection time, guaranteed specificity, and optimized operating parameters

Active Publication Date: 2022-03-11
苏州正济药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0019] Impurity 0114 There is no detection method for separating the above-mentioned intermediates and impurities in the prior art

Method used

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  • Analysis method for separating and detecting oseltamivir phosphate intermediate and impurities thereof
  • Analysis method for separating and detecting oseltamivir phosphate intermediate and impurities thereof
  • Analysis method for separating and detecting oseltamivir phosphate intermediate and impurities thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0055]Preparation of system test solution: Take an appropriate amount of oseltamivir phosphate intermediate and the above impurities 0103, 0104, 0105, 0109, 0111, 0112, 0114, dissolve and dilute with acetonitrile-water (30:70) to obtain oseltamivir phosphate The concentration of the intermediate is 1.0mg / ml, and the system test solution of each impurity is 2μg / ml;

[0056] Preparation of impurity localization solution: Dissolve and dilute appropriate amounts of the above impurities 0103, 0104, 0105, 0109, 0111, 0112, and 0114 with a solvent (acetonitrile-water (30:70)) to obtain a localization solution with a concentration of each impurity of 0.1 mg / ml. solution;

[0057] Use reversed-phase high-performance liquid chromatography to detect, detection conditions:

[0058] Column: Column model: Thermo scientific Hypersil GOLD TM ; Chromatographic column filler: octadecylsilane bonded silica gel; the specifications of the chromatographic column: the inner diameter is 4.6mm, the ...

Embodiment 2

[0069] Preparation of system test solution: Take an appropriate amount of oseltamivir phosphate intermediate and the above impurities 0103, 0104, 0105, 0109, 0111, 0112, 0114, dissolve and dilute with acetonitrile-water (30:70) to obtain oseltamivir phosphate The concentration of the intermediate is 1.0mg / ml, and the system test solution of each impurity is 2μg / ml;

[0070] Preparation of impurity localization solution: Dissolve and dilute appropriate amounts of the above impurities 0103, 0104, 0105, 0109, 0111, 0112, and 0114 with a solvent (acetonitrile-water (30:70)) to obtain a localization solution with a concentration of each impurity of 0.1 mg / ml. solution;

[0071] Use reversed-phase high-performance liquid chromatography to detect, detection conditions:

[0072] Chromatographic column: Chromatographic column model: YMC Pack-Pro C18; Chromatographic column packing: octadecylsilane bonded silica gel; Chromatographic column specifications: inner diameter 3.0mm, length 2...

Embodiment 3

[0082] Preparation of system test solution: Take an appropriate amount of oseltamivir phosphate intermediate and the above impurities 0103, 0104, 0105, 0109, 0111, 0112, 0114, dissolve and dilute with acetonitrile-water (30:70) to obtain oseltamivir phosphate The concentration of the intermediate is 1.0mg / ml, and the system test solution of each impurity is 2μg / ml;

[0083] Preparation of impurity localization solution: Dissolve and dilute appropriate amounts of the above impurities 0103, 0104, 0105, 0109, 0111, 0112, and 0114 with a solvent (acetonitrile-water (30:70)) to obtain a localization solution with a concentration of each impurity of 0.1 mg / ml. solution;

[0084] Use reversed-phase high-performance liquid chromatography to detect, detection conditions:

[0085] Column: Column model: Phenomenex Kinetex PFP Chromatographic column packing: pentafluorophenylsilane bonded silica gel; column specifications: inner diameter 4.6mm, length 150mm, packing particle size 5μm; ...

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Abstract

The invention discloses an analysis method for separating and detecting an oseltamivir phosphate intermediate and impurities thereof, belongs to the field of analytical chemistry, and particularly relates to an analysis method for carrying out gradient elution on the oseltamivir phosphate intermediate by taking pentafluorophenylsilane bonded silica gel as a filler, water-perchloric acid as a mobile phase A and acetonitrile-methanol as a mobile phase B. The method can realize effective separation and detection of the oseltamivir phosphate intermediate and the specific impurities thereof, has the characteristics of high detection sensitivity and accurate and reliable detection result, and provides a reliable reference method for quality research on separation and detection of the oseltamivir phosphate intermediate and the specific impurities thereof.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to an analysis method for separating and detecting an oseltamivir phosphate intermediate and specific impurities thereof. Background technique [0002] Oseltamivir phosphate is a neuraminidase inhibitor that can competitively bind to the active site of influenza virus neuraminidase and interfere with the release of the virus from infected host cells, thereby reducing influenza A and B It is widely used in the prevention and treatment of Influenza A and B. [0003] (1S,5R,6S)-5-(Pentyl-3-yloxy)-7-oxabicyclo[4.1.0]hept-3-ene-3-carboxylic acid ethyl ester is a synthetic oseltamivir phosphate An important intermediate, its molecular formula is: C 14 h 22 o 4 , the molecular weight is: 254.33; the structural formula is as follows: [0004] [0005] Impurity 0103 is the raw material product of oseltamivir phosphate intermediate, and its molecular formula is C 14 h ...

Claims

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Application Information

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IPC IPC(8): G01N30/88G01N30/34G01N30/89
CPCG01N30/88G01N30/34G01N30/89G01N2030/884G01N2030/8872G01N2030/027Y02P20/55
Inventor 王刚罗林王静何美菁吴雯郭辉
Owner 苏州正济药业有限公司
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