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Liquid chromatogram purity detection method for complete separation of tipiracil hydrochloride and related impurities

A technology for complete separation and purity detection, applied in the field of medicine, can solve the problems such as no patents or public literature reports on tipiracil hydrochloride, and achieve the effect of high sensitivity and good specificity

Pending Publication Date: 2017-10-20
江苏悦兴医药技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

After searching, there are currently no relevant patents or public literature reports on the analysis methods of tipiracil hydrochloride and its related substances

Method used

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  • Liquid chromatogram purity detection method for complete separation of tipiracil hydrochloride and related impurities
  • Liquid chromatogram purity detection method for complete separation of tipiracil hydrochloride and related impurities
  • Liquid chromatogram purity detection method for complete separation of tipiracil hydrochloride and related impurities

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0062] Verification uses tipiracil hydrochloride samples and the information of each impurity reference substance (its structure has been confirmed by testing).

[0063] name

batch number

source

Purity (HPLC method)

Tipiracil Hydrochloride

160820-2

self made

/

Impurity 1

20151101

Shenzhen Excellence Biotechnology Co., Ltd.

97.6％

Impurity 2

20150809

Shenzhen Excellence Biotechnology Co., Ltd.

99.5％

Impurity 3

20150809

Shenzhen Excellence Biotechnology Co., Ltd.

98.2％

Impurity 4 (starting material Ⅰ)

BH-B62078-150729

Shanghai Hanhong Chemical Technology Co., Ltd.

99.3％

Impurity 5 (starting material Ⅱ)

BH-B45026-151217

Shanghai Hanhong Chemical Technology Co., Ltd.

99.9％

Impurity 6 (intermediate)

20160823

self made

99.8％

[0064] Preparation method of each impurity stock solution, impurity reference solution, system suitability solution,...

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PUM

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Abstract

The invention discloses a liquid chromatogram purity detection method for complete separation of tipiracil hydrochloride and related impurities. According to the liquid chromatogram purity detection method, octadecyl silane bonded silica gel is taken as a chromatographic column of a filling, a buffer salt-ion pair-organic phase in a certain proportion is taken as a flow phase, the contents of tipiracil hydrochloride and related impurities are quantitatively determined in a gradient elution manner, and therefore, the mass of tipiracil hydrochloride is effectively controlled. The method has the advantages of strong specificity, high accuracy, simplicity and convenience in operation and the like.

Description

technical field [0001] The invention belongs to the technical field of medicines, and relates to the analysis and detection of medicines, in particular to a liquid chromatography purity detection method for completely separating tipiracil hydrochloride and its related impurities. Background technique [0002] Tipiracil hydrochloride is used as a main ingredient in the compound tablet Trifluridine hydrochloride tipiraxit for the treatment of unresectable or recurrent advanced colorectal cancer. Trifluridine hydrochloride tipiracil Composed of floxuridine and tipiracil hydrochloride, the metabolite of trifluridine monophosphate can be incorporated into DNA, exerts its antitumor effect by inhibiting the activity of thymidylate synthase, and is well absorbed after oral administration, but is easily absorbed by Degradation of thymidylate phosphorylase in the liver; tipiracil hydrochloride is a competitive inhibitor of trifluridine degrading enzyme, which can reduce the degradatio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/02G01N30/34
CPCG01N30/02G01N30/06G01N30/34
Inventor 赵旺明翟富民张静包华兰陈建丽
Owner 江苏悦兴医药技术有限公司