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Liquid chromatography determination method for ezetimibe tablet related substances

A technology of liquid chromatography and related substances, which is applied in the field of drug analysis, can solve the problems such as the detection method of substances A and B that have not been seen, and achieve high sensitivity and specificity, great application value and economic value, and simple operation Effect

Pending Publication Date: 2021-08-03
JIANGSU SIHUAN BIOENGINEERING PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0008] Therefore, for the impurities introduced during the synthesis of ezetimibe, quality control needs to be carried out in the raw material drug; so far, there is no method for the determination of substance A and substance B reported in the literature

Method used

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  • Liquid chromatography determination method for ezetimibe tablet related substances
  • Liquid chromatography determination method for ezetimibe tablet related substances
  • Liquid chromatography determination method for ezetimibe tablet related substances

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Embodiment Construction

[0031] Preferred embodiments of the present invention will be described in detail below in conjunction with the accompanying drawings.

[0032] It can be understood that the present invention achieves the purpose of the present invention through some embodiments. The present invention provides a liquid chromatography method for determining related substances in ezetimibe tablets, comprising the following steps:

[0033] S1 Prepare diluent solution

[0034] Take acetonitrile, methanol, glacial acetic acid and water, and mix them evenly according to the volume ratio of acetonitrile, methanol, glacial acetic acid and water at a ratio of 27:10:0.1:63 to prepare a diluent solution;

[0035] S2 preparation of mobile phase solution

[0036] Take acetonitrile, methanol and water, and mix them according to the volume ratio of acetonitrile, methanol and water at a ratio of 27:10:63 to prepare a mobile phase solution;

[0037] S3 preparation of the test solution

[0038] Take an appro...

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Abstract

The invention provides a liquid chromatogram determination method of ezetimibe tablet related substances, which comprises the steps of taking a system applicability solution, a sensitivity solution, a contrast solution and a test solution, injecting into a liquid chromatograph, recording a liquid chromatogram, and analyzing and determining the content of the substance A and the content of the substance B in the ezetimibe tablet according to the liquid chromatogram. The method can realize separation and determination of ezetimibe, the substance A and the substance B, has relatively high sensitivity and specificity, is simple and convenient to operate, can be used for quality control of the substance A and the substance B in the ezetimibe tablet, and has relatively high application value and economic value.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a liquid chromatography determination method for related substances in ezetimibe tablets. Background technique [0002] Ezetimibe, the chemical name is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S )-(4-hydroxyphenyl)-2-azetidin (azetidin) ketone, its chemical structural formula is as follows: [0003] [0004] Ezetimibe is the first FDA-approved selective inhibitor of cholesterol absorption for the treatment of primary hypercholesterolemia, homozygous familial hypercholesterolemia, homozygous sitosterolemia (or phytosterol Hyperemia) is an adjuvant therapeutic drug other than diet control. Combined with statins, it can be used as an adjuvant therapy for other blood lipid treatments, and has a good therapeutic effect. [0005] However, the study found that substance A and substance B are very similar to ezetimibe in terms of chemical structure, b...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/74G01N30/86B01J20/281
CPCG01N30/48G01N30/02G01N30/06G01N30/34G01N30/74G01N30/8679
Inventor 江永红丁月萍刘蕾刘红袁菊凤
Owner JIANGSU SIHUAN BIOENGINEERING PHARM CO LTD
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