Liquid phase analysis method of maleic acid asenapine and impurities thereof

A technology for asenapine maleate and impurities, which is applied in the field of analytical chemistry, can solve problems such as incomplete removal of intermediates, affecting the purity and quality of drugs, and achieve the effect of ensuring quality control
CN104297366AInactive Publication Date: 2015-01-21AVENTIS PHARMA HAINAN
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
AVENTIS PHARMA HAINAN
Publication Date
2015-01-21
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention belongs to the field of analytical chemistry and discloses a method for separating and determining maleic acid asenapine and impurities thereof by a liquid chromatography. The method adopts a chromatographic column taking octyl silane bonded silica gel as a filler, buffer salt solution-organic phase with certain proportion is used as a moving phase, the contents of the maleic acid asenapine and the impurities thereof can be quantitatively determined, and the quality of the maleic acid asenapine can be effectively controlled. The method has strong specificity, high accuracy and convenience in operation.
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Description

technical field

[0001] The invention belongs to the field of analytical chemistry, in particular to a method for liquid chromatography separation and determination of asenapine maleate and its impurities. Background technique

[0002] Asenapine maleate for acute mania or bipolar disorder with / without psychosis. Asenapine maleate chemical name (3aRS,12bRS) -5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-1 H -dibenzo[2,3:6,7]oxepino[4,5-c]pyrrole(2Z)-2-butenedioate(1:1), the molecular formula is C 21 h 20 ClNO 5 . The structural formula of asenapine maleate is:

[0003]

[0004] In the process of synthesizing the compound, some important intermediates may be incompletely removed, and degradation impurities may also be produced during the transportation and storage of the compound, and these incompletely removed intermediates and degradation impurities will affect the purity and quality. There are 7 impurities that need to be controlled for asenapine maleate, which are impu...

Claims

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