Method for detecting impurity phenylhydrazine in edaravone

Abstract

The invention belongs to the field of pharmaceutical analysis and specifically relates to a method for detecting impurity phenylhydrazine in edaravone. The invention aims to provide a conveniently operated, quick and accurate method for detecting the phenylhydrazine. The method comprises the following steps of: controlling a key HPLC (High Performance Liquid Chromatography) detecting condition by adopting liquid chromatogram detection, wherein for a moving phase, a volume percent of acetate buffer solution to carbinol is (70%-90%):(10%-30%) or the volume percent of acetate buffer solution to acetonitrile is (70%-90%):(10%-30%); the concentration of the acetate buffer solution is 0.04-0.06mol/L and pH value is 6.4-6.8; the detection wavelength is 226-238nm; the flow speed is 0.6-1.2ml/min; and the column temperature is 10-35 DEG C. The key detection parameters are controlled, so that the convenient, quick and accurate detecting purpose is achieved. The method provided by the invention has the advantages of convenience for operation accuracy and reliability in detecting result, stronger specificity, and shorter detection time because the main peak retention time is 9 minutes, and provides a brand new choice for detecting the impurity and controlling the product quality.

Description

technical field [0001] The invention belongs to the field of drug analysis, and in particular relates to a detection method for edaravone impurity phenylhydrazine. Background technique [0002] Edaravone is a brain protectant (free radical scavenger). The chemical name is 3-methyl-1-phenyl-2-pyrazolin-5-one; the molecular formula is: C 10 h 10 N 2O ; The chemical structure is as follows [0003] [0004] Clinical studies have shown that N-acetylaspartic acid (NAA) is a specific marker of surviving nerve cells, and its content decreases sharply in the early stage of cerebral infarction. The administration of edaravone to patients in the acute stage of cerebral infarction can inhibit the reduction of local cerebral blood flow around the infarction, and make the NAA content in the brain significantly higher than that of the glycerol control group on the 28th day after the onset. Mechanism studies suggest that Edaravone can scavenge free radicals and inhibit lipid peroxi...

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However, these two methods have different defects, which limit the acc

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