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Method for determining efinaconazole related substances by HPLC (High Performance Liquid Chromatography) method

A technology related to substances, potassium dihydrogen phosphate, applied in the field of analytical chemistry, can solve problems such as low efficiency

Pending Publication Date: 2021-05-21
广东东阳光药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to existing literature reports, the detection method for related substances of efluconazole uses a phosphate-methanol-acetonitrile system, and the analysis time takes 50 minutes, which is inefficient

Method used

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  • Method for determining efinaconazole related substances by HPLC (High Performance Liquid Chromatography) method
  • Method for determining efinaconazole related substances by HPLC (High Performance Liquid Chromatography) method
  • Method for determining efinaconazole related substances by HPLC (High Performance Liquid Chromatography) method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072]Instruments and chromatography conditions:

[0073]Chromatographic system: USA Agilent 1260 high-performance liquid chromatography system and workstation;

[0074]Columns: Mn Nucleshell RP18-Plus, 4.6x100mm, 2.7 μm;

[0075]Detector: UV detector;

[0076]Test wavelength: 210 nm;

[0077]Mobile phase a phase: 1.36 g / L of pelicate solution, adjusting pH to 6.5 with phosphoric acid, wherein the volume ratio of pelicine dihydrogen phosphate solution and acetonitrile is 95: 5;

[0078]Mobile phase B phase: mixed solvent of acetonitrile with methanol, wherein the volume ratio of acetonitrile to methanol is 3: 1;

[0079]The gradient elution procedure is as follows;

[0080]

[0081]Chromatography column temperature: 30 ° C;

[0082]Flow rate: 1.0ml / min;

[0083]Number of injections: 10 μL.

[0084]Experimental steps:

[0085]Diluent / Blank Solvent: Acetonitrile: Water = 50: 50 (V / V);

[0086]Try to test the sample: Take about 25 mg of Aiflufluornazole to the test product, precisely weighted to 25 ml of brown volumetr...

Embodiment 2

[0090]Instruments and chromatography conditions:

[0091]Chromatographic system: USA Agilent 1260 high-performance liquid chromatography system and workstation;

[0092]Columns: Mn Nucleshell RP18-Plus, 4.6x100mm, 2.7 μm;

[0093]Detector: UV detector;

[0094]Test wavelength: 210 nm;

[0095]Mobile phase a phase: 1.36 g / L of pelicate solution, adjusting pH to 6.5 with phosphoric acid, wherein the volume ratio of pelicine dihydrogen phosphate solution and acetonitrile is 95: 5;

[0096]Mobile phase B phase: mixed solvent of acetonitrile with methanol, wherein the volume ratio of acetonitrile to methanol is 3: 1;

[0097]The gradient elution procedure is as follows;

[0098]

[0099]Chromatography column temperature: 20 ° C;

[0100]Flow rate: 1.0ml / min;

[0101]Number of injections: 10 μL.

[0102]Experimental steps:

[0103]Diluent / Blank Solvent: Acetonitrile: Water = 50: 50 (V / V);

[0104]Try to test the sample: Take about 25 mg of Aiflufluornazole to the test product, precisely weighted to 25 ml of brown volumetr...

Embodiment 3

[0108]Instruments and chromatography conditions:

[0109]Chromatographic system: USA Agilent 1260 high-performance liquid chromatography system and workstation;

[0110]Columns: Mn Nucleshell RP18-Plus, 4.6x100mm, 2.7 μm;

[0111]Detector: UV detector;

[0112]Test wavelength: 210 nm;

[0113]Mobile phase a phase: 1.36 g / L of pelicate solution, adjusting pH to 6.5 with phosphoric acid, wherein the volume ratio of pelicine dihydrogen phosphate solution and acetonitrile is 95: 5;

[0114]Mobile phase B phase: mixed solvent of acetonitrile with methanol, wherein the volume ratio of acetonitrile to methanol is 3: 1;

[0115]The gradient elution procedure is as follows;

[0116]

[0117]Chromatography column temperature: 15 ° C;

[0118]Flow rate: 1.0ml / min;

[0119]Number of injections: 10 μL.

[0120]Experimental steps:

[0121]Diluent / Blank Solvent: Acetonitrile: Water = 50: 50 (V / V);

[0122]Try to test the sample: Take about 25 mg of Aiflufluornazole to the test product, precisely weighted to 25 ml of brown volumetr...

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Abstract

The invention belongs to the field of analytical chemistry, and particularly relates to a method for determining efinaconazole and related substances thereof by an HPLC (High Performance Liquid Chromatography) method. The method is characterized in that by taking an octadecylsilane bonded phase as a chromatographic column of a stationary phase, a mixed solution of a phosphate buffer solution and acetonitrile as a phase A, and a mixed solvent of acetonitrile and methanol as a phase B, the related substances in the efinaconazole raw material medicine and the preparation thereof are separated and determined. According to the method disclosed by the invention, the time in separating and detecting the efinaconazole and the related substances thereof is 31 minutes, and the efinaconazole and the related substances thereof can be simply, quickly and accurately separated and detected.

Description

Technical field[0001]The present invention belongs to the analysis of the analysis of chemicals, and in particular to methods of determining the substance of Aecfloffazole by HPLC.Background technique[0002]Aifluflofloxazole (English Name: Efinaconazole, trade name JUBLIA), chemical name (2R, 3R) -2- (2,4-difluorophenyl) -3- (4-methylene-1-piivi Butyry) -1- (1H-1, 2, 4-triazole-1-yl) -2-butanol, its structural formula is as follows:[0003][0004]Aifflofloxazole is a triazole antifungal drug developed by Japan's Kaken Pharmaceutical Company, Canadian Vlexant International Pharmaceutical Company, mainly used for the treatment of toes ash nail.[0005]Aifflofluozole raw materials and formulations have the following three sources: one is the raw materials, intermediates, degrades brought in this product synthesis; second is a by-product generated in the synthesis reaction; three is the storage process Degradation products produced due to the environmental impact.[0006]Quality control is requ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74
CPCG01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74G01N2030/324
Inventor 范晓梅马培丽欧晨颖栾保磊饶万兵刘国柱
Owner 广东东阳光药业股份有限公司
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