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Method for detecting favipiravir and related substances thereof by means of HPLC and application thereof

A technology for favipiravir and related substances, which is applied in the field of high-performance liquid chromatography to detect favipiravir and related substances, and can solve the problems of difficulty in effective separation and detection, inability to know related substances, and inability to clarify related substances and the like. , to achieve the effect of shortening the peak time, shortening the production and testing cycle, and ensuring the quality and safety of drugs

Pending Publication Date: 2021-08-13
BEIJING SIHUAN PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method has the following defects: one is that no specific information on any related substances of favipiravir is given, so it is impossible to know the related substances that it can detect; The third is that only one related substance in the favipiravir preparation has been detected, and it is difficult to effectively separate and detect a variety of related substances in favipiravir and its preparations

Method used

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  • Method for detecting favipiravir and related substances thereof by means of HPLC and application thereof
  • Method for detecting favipiravir and related substances thereof by means of HPLC and application thereof
  • Method for detecting favipiravir and related substances thereof by means of HPLC and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0135] 1, column: Techmate C18-ST, 250 × 4.6mm, 5μm

[0136] 2, mobile phase:

[0137] A phase: pH 5.0, concentration of 0.15% apirammonium phosphate solution (1.5 g of dihydrogen phosphate, dissolved with water and diluted to 1000 ml, plus triethylamine 5ml, tetrabutylal sulfate 6.8 g, mix) , Phosphoric acid pH value to 5.0)

[0138] B phase: methanol

[0139] 3, flow rate: 1 ml / min, in-sample: 10μL

[0140] 4, detector: DAD detector, detection wavelength: 230 nm and 290 nm, column temperature: 30 ° C

[0141] 5, dissolved solvent: pH 7.0, concentration of 0.15% pH of apihydrogen phosphate solution

[0142] Gradient elution conditions:

[0143]

[0144] Take the method of tripraway, impurities A, impurity B, impurity C, impurities D, impurities E, impurity G, impurity F and impurity H, the concentration of 0.15% apihydrogen phosphate solution (1.5 g of dihydrogen phosphate) The water was dissolved and diluted to 1000 ml, 5 ml of triethylamine, mixed, cosmetic acid pH to 7.0) ...

Embodiment 2

[0150] 1, column: Agela Venusil XBP C18 (A) column, 4.6 × 250mm, 5μm

[0151] 2, mobile phase

[0152] A phase: pH 5.0, concentration of 0.15% apirammonium phosphate solution (1.5 g of dihydrogen phosphate, dissolved with water and diluted to 1000 ml, plus triethylamine 5ml, tetrabutylal sulfate 6.8 g, mix) , Phosphoric acid pH value to 5.0)

[0153] B phase: methanol

[0154] 3, flow rate: 1.0ml / min, injection volume: 10μL

[0155] 4, detector: DAD detector, detection wavelength: 230 nm and 290 nm, column temperature: 28 ° C

[0156] 5, dissolved solvent: pH 7.0, concentration of 0.15% pH of apihydrogen phosphate solution

[0157] Gradient elution conditions:

[0158]

[0159] Solution formulation and concentration as in Example 1, see the chromatogram of the test Figure 4 The experimental data for the test product is shown in Table 5.

[0160] table 5

[0161]

[0162]

Embodiment 3

[0164] 1, column: Agela Venusil XBP C18 (A) column, 4.6 × 250mm, 5μm

[0165] 2, mobile phase:

[0166] A phase: pH 5.0, concentration of 0.15% apirammonium phosphate solution (1.5 g of dihydrogen phosphate, dissolved with water and diluted to 1000 ml, plus triethylamine 5ml, tetrabutylal sulfate 6.8 g, mix) , Phosphoric acid pH value to 5.0)

[0167] B phase: methanol

[0168] 3, flow rate: 0.8ml / min, injection volume: 10μL

[0169] 4, detector: DAD detector, detection wavelength: 230 nm and 290 nm, column temperature: 30 ° C

[0170] 5, dissolved solvent: pH 7.0, concentration of 0.15% pH of apihydrogen phosphate solution

[0171] Gradient elution conditions:

[0172]

[0173] Solution formulation and concentration as in Example 1, see the chromatogram of the test Figure 5 The experimental data for the test product is shown in Table 6.

[0174] Table 6

[0175]

[0176]

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Abstract

The invention relates to a method for detecting favipiravir related substances by means of high performance liquid chromatography. According to the method, octadecylsilane chemically bonded silica is used as a filler, the column temperature is 25-35 DEG C, the detection wavelength is 220-250 nm, a mobile phase is composed of a phase A and a phase B, the flow velocity of the mobile phase is 0.8-1.2 ml / min, the phase A is an aqueous solution with the pH value of 3.5-6.0, and the phase B is an organic solvent. According to the analysis method, the separation degree of different substances is good, and the safety, effectiveness and quality controllability of raw materials and preparations can be improved.

Description

Technical field [0001] The present invention belongs to the technical field of drug analysis, and more particularly to high performance liquid chromatography detection of macro and its related substances and its application. Background technique [0002] Favipiravir, Structure, Structure II) For RNA-dependent RNA polymerase (RDRP) inhibitors, broad-spectrum antiviral drugs, the drug to human beings to cope with martyrotic infectious diseases and possible creatures Terrorist attacks have important practical significance. [0003] [0004] Fabiraway is unstable under oxidation, strong acid, and strong base, which is prone to degrade, and the initial raw materials, intermediates, polymers, sub-reactive products, etc. introduced in the preparation of the preparation, become the quality of drug quality. The relevant material, so it needs to be controlled to protect the quality of drug quality and the safety of drugs, and realize the quality of the drug. [0005] CN104914185A disclos...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/32G01N30/34G01N30/54G01N30/06
CPCG01N30/02G01N30/32G01N30/34G01N30/54G01N30/06G01N2030/324G01N2030/047
Inventor 杨成娜刘严范建国邓声菊徐艳君王田园
Owner BEIJING SIHUAN PHARMA
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