A method for detecting genotoxic impurities in edaravone and its sodium chloride injection

A technology of sodium chloride injection and genotoxicity, which is applied in the field of genotoxic impurity detection of edaravone and its sodium chloride injection, can solve the problems of increasing adverse drug reactions, achieve good quality, scientific detection method, Simple operation effect

Active Publication Date: 2021-11-09
JIANGSU CHIA TAI FENGHAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Aniline and benzidine are the starting materials and process impurities of phenylhydrazine, and aniline can be detected in many batches of phenylhydrazine; both are carcinogenic and toxic substances, and if they are not completely removed, the purity, quality and efficacy of the drug will be affected. increase adverse drug reactions

Method used

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  • A method for detecting genotoxic impurities in edaravone and its sodium chloride injection
  • A method for detecting genotoxic impurities in edaravone and its sodium chloride injection
  • A method for detecting genotoxic impurities in edaravone and its sodium chloride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Embodiment 1 High-performance liquid chromatography measures Edaravone and its impurities, and investigates the separation effect of this condition

[0050] 1) Instruments and testing conditions:

[0051] Detector: UV detector, the detection wavelength is 226nm;

[0052] Chromatographic column: Octadecylsilane bonded silica gel (Kromasil C 18 , 4.6×250mm, 5μm applicable);

[0053] Column temperature: 30°C;

[0054] Mobile phase: the aqueous phase is 0.05mol / L ammonium dihydrogen phosphate solution (pH=4.0), and the organic phase is methanol;

[0055] Carry out gradient elution according to the following table, elution conditions:

[0056]

[0057] Mobile phase flow rate: 1.0ml / min;

[0058] Injection volume: 50 μl.

[0059] 2) Solution preparation

[0060] Take the appropriate amount of impurity 1 phenylhydrazine, impurity 2 aniline, impurity 3 benzidine, impurity 4, impurity 5, impurity 6, impurity 7 and Edaravone and its injection reference substance, accura...

Embodiment 2

[0065] Embodiment 2 High-performance liquid chromatography measures Edaravone and its impurities, and investigates the separation effect of this condition

[0066] 1) Instruments and testing conditions:

[0067] Detector: UV detector, the detection wavelength is 226nm;

[0068] Chromatographic column: Octadecylsilane bonded silica gel (Kromasil C 18 , 4.6×250mm, 5μm applicable);

[0069] Column temperature: 30°C;

[0070] Mobile phase: the aqueous phase is 0.05mol / L ammonium dihydrogen phosphate solution (pH=5.0); the organic phase is methanol;

[0071] Carry out gradient elution according to the following table, elution conditions:

[0072]

[0073] Mobile phase flow rate: 1.5ml / min;

[0074] Injection volume: 50 μl.

[0075] 2) The solution preparation method is the same as in Example 1.

[0076] 3) Measurement method and results

[0077] Inject samples according to 1) chromatographic conditions, and examine the separation between impurities. The results showed tha...

Embodiment 3

[0081] Embodiment 3 high performance liquid chromatography measures Edaravone and its impurity, investigates the separation effect of this condition

[0082] 1) Instruments and testing conditions:

[0083] Detector: UV detector, the detection wavelength is 224nm;

[0084] Chromatographic column: Octadecylsilane bonded silica gel (Kromasil C 18 , 4.6×250mm, 5μm applicable);

[0085] Column temperature: 20°C;

[0086] Mobile phase: the aqueous phase is 0.05mol / L ammonium dihydrogen phosphate solution (pH=3.0); the organic phase is methanol;

[0087] Carry out gradient elution according to the following table, elution conditions:

[0088]

[0089] Mobile phase flow rate: 0.5ml / min; injection volume: 50μl.

[0090] 2) The solution preparation method is the same as in Example 1.

[0091] 3) Measurement method and results

[0092] Inject samples according to 1) chromatographic conditions, and investigate the main component, each impurity, and the separation between each im...

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Abstract

The invention provides a method for detecting genotoxic impurities in edaravone and its sodium chloride injection. The method adopts high-performance liquid chromatography, uses octadecylsilane bonded silica gel or octadecylsilane bonded silica gel as a chromatographic column, and uses a mixed solvent of an organic phase and an aqueous phase as a mobile phase for gradient elution. Realized the separation of Edaravone and its related substances from the three genotoxic impurities in a short period of time, with high sensitivity and specificity, and achieved the separation between the main component and other related substances and genotoxic impurities and genotoxic impurities. The degree of separation is greater than 1.5. The method has simple process, low cost, scientific, reasonable and objective detection method, can better control the quality of edaravone, and has practical value.

Description

technical field [0001] The invention belongs to the field of drug analysis, and in particular relates to a method for detecting genotoxic impurities of edaravone and its sodium chloride injection for improving neurological symptoms, activities of daily living and dysfunction caused by acute cerebral infarction. Background technique [0002] Edaravone (Edaravone, 3-methyl-1-phenyl-2-pyrazolin-5-one) is currently one of the most effective drugs for the treatment of cerebral infarction, and its molecular formula is C 10 h 10 N 2 O, 174.20, the structural formula is: [0003] [0004] Edaravone injection is the first-line drug of choice for the treatment of cerebral infarction. The administration method of this product is intravenous infusion. Clinical studies suggest 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 th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 赵悦马利华杜柳辉叶海英
Owner JIANGSU CHIA TAI FENGHAI PHARMA
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