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Determination method of related substances in favipiravir

A technology related to substances and determination methods, applied in the field of drug analysis, can solve the problems of short detection time, long detection time, and low detection cost

Inactive Publication Date: 2021-06-04
ZHEJIANG HISUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The HPLC assay method of the related substance of favipiravir retrieved at present, its assay time is longer and needs to adopt diode array detector, has characteristics such as low sensitivity; Therefore it is necessary to develop detection cost low and detection time is shorter, high sensitivity, Determination method of favipiravir related substances with high specificity and good accuracy

Method used

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  • Determination method of related substances in favipiravir
  • Determination method of related substances in favipiravir
  • Determination method of related substances in favipiravir

Examples

Experimental program
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Effect test

Embodiment 1

[0028] Method description Chromatographic system: high performance liquid chromatography (ultraviolet absorption detector); chromatographic column (AQ-C18 and Ghost-Buster column); mobile phase: potassium dihydrogen phosphate solution (mobile phase A)-acetonitrile (mobile phase B) , where the concentration of potassium dihydrogen phosphate solution is 1.0mmol / L, and the pH is 2.5; diluent: 10mM sodium carbonate solution; column temperature: 35°C; flow rate: 1.0ml / min; detection wavelength: 225nm; total running time: 45min ; Gradient elution program:

[0029]

[0030]

[0031] linear

[0032] Accurately weigh an appropriate amount of Favipiravir reference substance and known impurity A reference substance solution, and use a diluent to make Favipiravir containing 0.15 μg / ml, 1.27 μg / ml, 2.02 μg / ml, 2.53 μg / ml and 5.06μg / ml solution, containing impurity A concentration of 0.23μg / ml, 0.39μg / ml, 0.62μg / ml, 0.78μg / ml and 1.56μg / ml solutions, injection analysis, injection vol...

Embodiment 2

[0046]Method description Chromatographic system: high performance liquid chromatography (ultraviolet absorption detector); chromatographic column (AQ-C18 and Ghost-Buster column); mobile phase: potassium dihydrogen phosphate solution (mobile phase A)-acetonitrile (mobile phase B) , where the concentration of potassium dihydrogen phosphate solution is 1.0mmol / L, and the pH is 2.5; diluent: 10mM sodium carbonate solution; column temperature: 35°C; flow rate: 1.0ml / min; detection wavelength: 225nm; total running time: 45min ; Gradient elution program:

[0047] time (minutes) Mobile phase A(%) Mobile phase B(%) 0 100 0 3 100 0 25 80 20 35 80 20 35.01 100 0 45 100 0

[0048] Reference substance solution preparation

[0049] Precisely weigh about 25mg of Favipiravir reference substance and place it in a 50ml measuring bottle, add an appropriate amount of diluent to ultrasonically dissolve and dilute to the mark, and mix well to o...

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Abstract

The invention relates to the field of analytical chemistry, and discloses a method for detecting related substances of favipiravir, which takes a phosphate solution (mobile phase A)-acetonitrile (mobile phase B) as a mobile phase and a sodium carbonate solution as a diluent. taking a proper amount of favipiravir and a proper amount of a tablet containing the favipiravir, adding a diluent to prepare a sample solution containing 0.5 mg / mL of the favipiravir, and adding the diluent to dilute the favipiravir into a reference substance solution of 2.5 [mu] g / mL; quantitatively determining the contents of related substances in the favipiravir and the preparation by adopting a main component and correction factor method. According to the method for detecting the related substances of the favipiravir , the conditions of impurities and degradation products of the favipiravir can be rapidly and accurately detected. Operation is easy and convenient, accuracy is good, sensitivity is high, and product quality can be well controlled.

Description

technical field [0001] The invention relates to a method for detecting related substances of favipiravir and tablets containing favipiravir, belonging to the field of drug analysis. Background technique [0002] Favipiravir, whose chemical name is 6-fluoro-3-hydroxypyrazine-2-carboxamide, is a novel RNA-dependent RNA polymerase (RdRp) inhibitor belonging to the spectrum anti-influenza virus drug for the treatment of adult New or recurring influenza. Since favipiravir may produce by-products and other related substances during the synthesis process, and may also produce degradation products during storage, the present invention uses liquid chromatography to quickly detect the related substances of the favipiravir preparation. Ensure the quality of its preparations is controllable. The HPLC assay method of the related substance of favipiravir retrieved at present, its assay time is longer and needs to adopt diode array detector, has characteristics such as low sensitivity; T...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/74
CPCG01N30/02G01N30/06G01N30/74
Inventor 李宏杰陈小艳谭奕高华
Owner ZHEJIANG HISUN PHARMA CO LTD
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