Method for measuring genotoxic impurities in pradaxa

A technology of dabigatran etexilate mesylate and genotoxicity, which is applied in the field of drug analysis and can solve problems such as causing cancer

Inactive Publication Date: 2015-11-25
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, in the synthesis of dabigatran etexilate mesylate, sulfonic acid substances and trace amounts of lower alcohols generate alkyl sulfonate such as methyl methanes

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Instrument: Agilent1260 high performance liquid chromatography, 1260 ultraviolet detector

[0026] Chromatographic column: a chromatographic column (250×4.6mm, 5μm) filled with octadecylsilane bonded silica gel;

[0027] Mobile Phase A: Acetonitrile

[0028] Mobile phase B: 0.01mol / L phosphate buffer (pH4.5)

[0029] See the table below for gradient elution;

[0030] time (min) Mobile Phase A(%) Mobile Phase B(%) 0-20 90 10 20-30 70 30 30-50 90 10

[0031] Flow rate: 0.8mL / min

[0032] Detection wavelength: 220nm

[0033] Column temperature: 25°C

[0034] Injection volume: 10μL

[0035] Diluent: Acetonitrile

[0036] experiment procedure:

[0037] Need testing solution: take dabigatran etexilate mesylate sample 1.0014g and put in a 10mL measuring bottle, dissolve and dilute to the mark with diluent, and shake up.

[0038] Reference substance solution: Accurately weigh 10.08mg each of methyl methanesulfonate and ethyl methanesu...

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PUM

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Abstract

The invention discloses a method for measuring genotoxic impurities in pradaxa. According to the method, octadecylsilane chemically bonded silica is taken as a chromatographic column of a stationary phase, and a mixed solvent of an organic phase and a buffer is performed with gradient elution to be taken as a mobile phase for direct detection. The detection method has the advantages of high detection sensitivity, strong specialization, high precision, strong accuracy and convenient operation; has wide applicability, and can effectively control the quality of bulk drug.

Description

technical field [0001] The invention belongs to the field of drug analysis, and in particular relates to a method for measuring genotoxic impurities in dabigatran etexilate mesylate by using HPLC (high performance liquid chromatography). Background technique [0002] Dabigatran etexilate mesylate is the prodrug of dabigatran, which was developed by Boehringer Ingelheim of Germany. It was first listed in Germany and the UK in April 2008. It is a new class of oral anticoagulant drugs, which is a major progress in the field of anticoagulant therapy and the prevention of potentially fatal thrombosis, with milestone significance. [0003] However, in the synthesis of dabigatran etexilate mesylate, sulfonic acid substances and trace amounts of lower alcohols generate alkyl sulfonate such as methyl methanesulfonate (MMS), ethyl methanesulfonate (EMS) in the synthesis reaction. ), these substances can undergo alkylation reactions with DNA, which may become the cause of cancer. [...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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