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Impurity detection method of edaravone sodium chloride injection

A technology of edaravone sodium chloride and a detection method, which is applied in the field of drug analysis and can solve problems such as being unable to be used for detection and separation

Pending Publication Date: 2021-07-16
YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The method adopts high-performance liquid chromatography, using octadecylsilane bonded silica gel or octadecylsilane bonded silica gel as a chromatographic column as a filler, and an organic phase (methanol or acetonitrile) and an aqueous phase (ammonium dihydrogen phosphate solution) ) mixed solvent as the mobile phase for gradient elution, which achieved the separation of Edaravone and its related substances from the three genotoxic impurities in a short period of time, but could not be used to detect and separate the impurities in this application

Method used

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  • Impurity detection method of edaravone sodium chloride injection
  • Impurity detection method of edaravone sodium chloride injection
  • Impurity detection method of edaravone sodium chloride injection

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Embodiment 1

[0053] The present embodiment provides a method for detecting impurities of Edaravone Sodium Chloride Injection, said detection method comprising the following steps: preparing Edaravone Sodium Chloride Injection into a test solution, and adopting C18 reverse phase chromatography The column uses the mixed solvent of mobile phase A and mobile phase B as the mobile phase gradient elution to detect Edaravone and impurities;

[0054] Instrument: Agilent 1260 high performance liquid chromatograph

[0055] Chromatographic column: Tskgel ODS-100Z C18, 4.6mm×250mm, 5μm

[0056] Detection wavelength: 240nm, 225nm

[0057] Flow rate: 1.0mL / min

[0058] Concentration of the test solution: 0.3mg / mL

[0059] Injection volume: 20μL

[0060] Mobile phase A: 0.1wt% phosphoric acid in water

[0061] Mobile phase B: 0.1wt% methanolic phosphoric acid solution

[0062] Carry out gradient elution according to Table 1:

[0063] Table 1

[0064]

[0065] figure 1 The high performance liq...

Embodiment 2

[0069] The present embodiment provides a method for detecting impurities of Edaravone Sodium Chloride Injection, said detection method comprising the following steps: preparing Edaravone Sodium Chloride Injection into a test solution, and adopting C18 reverse phase chromatography The column uses the mixed solvent of mobile phase A and mobile phase B as the mobile phase gradient elution to detect Edaravone and impurities;

[0070] Instrument: Waters e2695 high performance liquid chromatography

[0071] Chromatographic column: Waters Xbridge C18, 4.6mm×250mm, 5μm

[0072] Detection wavelength: 243nm, 227nm

[0073] Flow rate: 0.8mL / min

[0074] Concentration of the test solution: 0.3mg / mL

[0075] Injection volume: 20μL

[0076] Mobile phase A: 0.2% phosphoric acid in water

[0077] Mobile phase B: 0.2% methanolic phosphoric acid solution

[0078] Carry out gradient elution according to Table 3:

[0079] table 3

[0080]

[0081] figure 2 The high-performance liquid...

Embodiment 3

[0085] The present embodiment provides a method for detecting impurities of Edaravone Sodium Chloride Injection, said detection method comprising the following steps: preparing Edaravone Sodium Chloride Injection into a test solution, and adopting C18 reverse phase chromatography The column uses the mixed solvent of mobile phase A and mobile phase B as the mobile phase gradient elution to detect Edaravone and impurities;

[0086] Instrument: Waters e2695 high performance liquid chromatography

[0087] Chromatographic column: Tskgel ODS-100Z C18, 4.6mm×250mm, 5μm

[0088] Detection wavelength: 240nm, 225nm

[0089] Flow rate: 1.2mL / min

[0090] Concentration of the test solution: 0.3mg / mL

[0091] Injection volume: 20μL

[0092] Mobile phase A: 0.1% phosphoric acid in water

[0093] Mobile phase B: 0.1% methanolic phosphoric acid solution

[0094] Carry out gradient elution according to Table 5:

[0095] table 5

[0096]

[0097] image 3 The high-performance liquid...

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Abstract

The invention provides an impurity detection method of an edaravone sodium chloride injection. The method comprises the following steps: preparing the edaravone sodium chloride injection into a test solution, carrying out gradient elution by adopting a C18 reversed-phase chromatographic column and taking a mixed solvent of a mobile phase A and a mobile phase B as a mobile phase, and detecting edaravone and impurities, wherein the mobile phase A is a phosphoric acid aqueous solution, and the mobile phase B is a phosphoric acid methanol solution. The detection method disclosed by the invention enhances the separation effect in a mobile phase system, can effectively separate and comprehensively detect all impurities disclosed by an original development agent, improves the separation effect of the system, and is simple and convenient to operate and accurate in detection.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to an impurity detection method for edaravone sodium chloride injection. Background technique [0002] Edaravone (Edaravone, 3-methyl-1-phenyl-2-pyrazolin-5-one) is a pyrazolone compound synthesized from phenylhydrazine and ethyl acetoacetate, which has a powerful free radical Scavenging effect, its molecular weight is C 10 h 10 N 2 O, the molecular weight is 174.20, and the structural formula is: [0003] [0004] Edaravone is a brain protectant (free radical scavenger), developed by Mitsubishi Tokyo Pharmaceutical Co., Ltd., and first listed in Japan in 2001. It can effectively reduce neurological symptoms and dysfunction caused by brain tissue damage after cerebral infarction. Clinically, it is mainly used for the treatment of acute ischemic stroke, and it also has a good effect on the treatment of amyotrophic lateral sclerosis. In recent years, with the development...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/74G01N30/89
CPCG01N30/02G01N30/74G01N30/89Y02A50/30
Inventor 吴亮
Owner YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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