Analysis method of estriol

An analysis method, the technology of estriol, is applied in the direction of analyzing materials, material separation, measuring devices, etc., to achieve the effect of good separation and accuracy, high sensitivity and good separation

Active Publication Date: 2014-04-16
CHINA RESOURCES ZIZHU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] In order to solve the problem of the analysis method of estriol in the prior art, the present invention provides a reversed-phase chromatographic column with better hydrophilicity, and adopts the method of gradient elution to separate estriol and magazines. The method of the present invention is suitable for Analytical method for crude estriol with more impurities

Method used

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  • Analysis method of estriol
  • Analysis method of estriol

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Experimental program
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Effect test

Embodiment 1

[0025] Solution preparation: Accurately weigh 20mg of crude estriol, put it in a 20ml measuring bottle, dilute with methanol and make up to volume, shake well.

[0026] Chromatographic conditions: hydrophilic octadecylsilane bonded silica gel column (5um, 4.6×250mm), mobile phase is acetonitrile-water, flow rate: 1.0ml / min, column temperature: 30°C, detection wavelength: 280nm, into The sample volume is 20ul.

[0027] Gradient elution: the volume ratio of acetonitrile to water: 0-10 minutes, 10-20: 90-80; 10-30 minutes, 60-80: 40-20; 30-55 minutes, 60-70: 40-30.

Embodiment 2

[0029] Solution preparation: Accurately weigh 20mg of crude estriol, put it in a 20ml measuring bottle, dilute with methanol and make up to volume, shake well.

[0030] Chromatographic conditions: hydrophilic octadecylsilane bonded silica gel column (5um, 4.6×250mm), mobile phase is acetonitrile-water, flow rate: 1.0ml / min, column temperature: 30°C, detection wavelength: 280nm, into The sample volume is 20ul.

[0031] Gradient elution: The volume ratio of acetonitrile to water is: 0-10 minutes, 30-40:70-60; 10-30 minutes, 20-40:80-60; 30-55 minutes, 80:20.

Embodiment 3

[0033] Solution preparation: Accurately weigh 20mg of crude estriol, put it in a 20ml measuring bottle, dilute with methanol and make up to volume, shake well.

[0034] Chromatographic conditions: hydrophilic octadecylsilane bonded silica gel column (5um, 4.6×250mm), mobile phase is acetonitrile-water, flow rate: 1.0ml / min, column temperature: 30°C, detection wavelength: 280nm, into The sample volume is 20ul.

[0035] Gradient elution: the volume ratio of acetonitrile to water: 0-10 minutes, 20-30: 80-70; 10-30 minutes, 40-60: 60-40; 30-55 minutes, 70-80: 30-20.

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Abstract

The invention relates to an analysis method of a medicine, in particular to an analysis method of estriol. The analysis method of estriol adopts a hydrophilic reversed phase column; a moving phase consists of acetonitrile and water; and an eluting method adopts gradient elution. With the adoption of the method, related substances in a crude estriol product can be separated better.

Description

technical field [0001] The invention relates to an analysis method of medicine, in particular to an analysis method of estriol. Background technique [0002] There are many patents for the preparation method of estriol, but due to the introduction of too many impurities in the preparation process of estriol, it is difficult to purify, and the most important impurity is the isomer (impurity E) of estriol. [0003] The European Pharmacopoeia (EP7.2) adopts high performance liquid chromatography (normal phase chromatography system), but this method cannot effectively separate the related substances in the crude estriol, which affects quality control; the peak shape of the chromatographic peak is poor, and the peak broadening is serious ; Affect the product quality control; the normal phase chromatographic system has poor durability and is inconvenient to use; the normal phase chromatographic column has a short service life, and the chromatographic column and mobile phase reagen...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 杨柳赵娜许乃茜谢姝赵红欣唐四华丁晓勇
Owner CHINA RESOURCES ZIZHU PHARMA
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