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A method for detecting related substances in perampanel tablets

A technology of perampanel tablets and related substances, applied in the field of drug analysis, can solve problems such as incomplete description, achieve high accuracy and precision, good reproducibility, and facilitate the control of product quality

Active Publication Date: 2020-08-21
NANJING HEALTHNICE MEDICAL TECH +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no complete description of the detection methods for related substances in perampanel tablets

Method used

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  • A method for detecting related substances in perampanel tablets
  • A method for detecting related substances in perampanel tablets
  • A method for detecting related substances in perampanel tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0052] Embodiment: A kind of HPLC detection method of related substances of perampanel

[0053] 1. Experimental materials and instruments

[0054] 1. Drugs and reagents: perampanel tablets (Eisai R&D Management Co.Ltd), phenylboronic acid (impurity 2, Jiaxing Eisen Chemical Co., Ltd.), 2-cyanophenylboronic acid-1,3-propanediol cyclic ester ( Impurity 3, Nanjing Haina Pharmaceutical Technology Co., Ltd.), 1-phenyl-5-(2-pyridyl)-1,2-dihydropyridin-2-one (impurity 4, Nanjing Haina Pharmaceutical Technology Co., Ltd.), 1-phenyl-3-bromo-5-(2-pyridyl)-1,2-dihydropyridin-2-one (impurity 5, Nanjing Haina Pharmaceutical Technology Co., Ltd.), 1,5-diphenyl- [2,3'-bipyridine]-6'(1'H)-one (impurity 6, Nanjing Haina Pharmaceutical Technology Co., Ltd.), 3-(6-oxo-1-phenyl-1,6-di Hydrogen-[2,3-bipyridyl]-5-yl)benzonitrile (impurity 7, Nanjing Haina Pharmaceutical Technology Co., Ltd.), 4-(6-oxo-1-phenyl-1,6-dihydro- [2,3-bipyridyl]-5-yl)benzonitrile (impurity 8, Nanjing Haina Pharmaceutic...

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Abstract

The invention relates to a method for detecting a substance related to fycompa tablets, and belongs to the technical field of drug analysis. The detection method provided by the invention adopts a mobile phase A and a mobile phase B as a mixed mobile phase for gradient elution, wherein the mobile phase A is an aqueous phase, and the mobile phase B is an organic phase; the initial ratio of the mobile phase A to the mobile phase B in gradient elution process is (25-35):(75-65) or 70:30; within 0-8 minutes, the volume ratio of the mobile phase A to the mobile phase B remains unchanged; within 8-30 minutes, the volume ratio of the mobile phase A to the mobile phase B is gradually changed from the initial ratio to 40:60 at a constant speed; within 30-40 minutes, the volume ratio of the mobile phase A to the mobile phase B remains unchanged at 40:60; within 40 to 50 minutes, the volume ratio of the mobile phase A to the mobile phase B is gradually changed from 40:60 to 70:30 at a constant speed; and within 50 to 60 minutes, the volume ratio of the mobile phase A to the mobile phase B remains unchanged at 70:30.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a method for detecting related substances of perampanel tablets. Background technique [0002] Perampanel is a drug developed by Japan's Eisai Company, which is used to treat partial seizures in epilepsy patients over 12 years old through non-competitive inhibition of AMPA-type glutamate receptors. The drug is the first antiepileptic drug with this mechanism of action approved by the FDA. [0003] Related substances are the starting materials, intermediates, side reaction products and degradation impurities brought in during the drug synthesis and production process. The detection of related substances can control the quality and safety of drugs. At present, there is no complete description of the detection method for related substances in perampanel tablets. Contents of the invention [0004] The object of the present invention is to provide a method for detecting rela...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/34G01N30/06G01N30/14G01N30/74G01N30/86G01N30/04
CPCG01N30/02G01N30/04G01N30/06G01N30/14G01N30/34G01N30/74G01N30/8634G01N2030/047G01N2030/146
Inventor 杨雨菲朱峰妍孙莉莉
Owner NANJING HEALTHNICE MEDICAL TECH
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