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Method for separating and detecting brexpiprazole impurities by adopting gas chromatography

A gas chromatography and epipiprazole technology, which is applied in the field of drug analysis, can solve the problem that the limit requirements of genotoxic impurities cannot be met, and the detection method of 1,4-dichlorobutane impurities and 1,4-dibromobutane impurities Report, low sensitivity and other problems, to achieve the effect of good durability, good specificity, and high sensitivity

Pending Publication Date: 2022-06-21
YAOPHARMA CO LTD +1
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Problems solved by technology

[0005] The announcement number is the Chinese patent document of CN106770746B, discloses a kind of high performance liquid chromatography, adopts standard curve method to measure the 1-bromine in the ebiprazole intermediate -4-chlorobutane, but the sensitivity of this method is low. According to the signal-to-noise ratio of 10:1, the limit of quantification of 1-bromo-4-chlorobutane is 25.8ng; according to the signal-to-noise ratio equal to 3:1, 1 -Bromo-4-chlorobutane has a detection limit of 7.74ng, which cannot meet the genotoxic impurity limit requirements
[0006] At present, there is no report on the detection method of 1,4-dichlorobutane impurity and 1,4-dibromobutane impurity in ebiprazole

Method used

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  • Method for separating and detecting brexpiprazole impurities by adopting gas chromatography
  • Method for separating and detecting brexpiprazole impurities by adopting gas chromatography
  • Method for separating and detecting brexpiprazole impurities by adopting gas chromatography

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Experimental program
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Effect test

Embodiment 1

[0033] Take the above-mentioned reference substance solution and accuracy test solution, inject samples according to the above-mentioned chromatographic conditions, and record the chromatograms. The results are shown in Table 6:

[0034] In summary, under this chromatographic condition, 1-bromo-4-chlorobutane, 1,4-dichlorobutane and 1,4-dibromobutane in ebiprazole bulk drug can be effectively detected with high sensitivity , strong specificity, high accuracy, and easy operation.

[0035] Example 3

[0036] Measure the reference substance solution according to the method of embodiment 1, the result shows that in the reference substance solution, the resolution of the target peak and the adjacent peak is greater than 1.5, and the resolution data are shown in Table 7:

[0037] Example 4

[0038] Measure the reference substance solution according to the method of embodiment 1, the result shows that in the reference substance solution, the resolution of the target peak and the a...

Embodiment 2

Embodiment 3

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Abstract

The invention provides a method for separating and determining 1-bromo-4-chlorobutane, 1, 4-dichlorobutane and 1, 4-dibromobutane in brexpiprazole, which adopts a gas chromatographic method, and adopts a capillary column taking 5% phenyl-95% dimethyl polysiloxane as a stationary liquid as a chromatographic column. The method can be used for quality control of brexpiprazole.

Description

technical field [0001] The invention belongs to the field of drug analysis methods, in particular to a method for separating and measuring 1-bromo-4-chlorobutane, 1,4-dichlorobutane and 1,4-dibromobutane in ebiprazole by gas chromatography Methods. Background technique [0002] Ebiprazole is an atypical antipsychotic drug jointly developed by Lundbeck Pharmaceuticals of Denmark and Otsuka of Japan. Its pharmacological mechanism may be through the serotonin 5-HT1A and dopamine D2 receptor partial agonist activity, and the serotonin 5- mediated by a combination of HT2A receptor antagonist activities. Its preparation is a tablet. The product was launched in the United States on July 10, 2015, in Japan on January 19, 2018, and in the European Union on July 27, 2018. It is not currently on the market in China. It is approved for the adjunctive treatment of major depressive disorder (MDD) and for the treatment of schizophrenia. [0003] The chemical name of ebiprazole is 7-(4-(...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/60G01N30/68
CPCG01N30/02G01N30/06G01N30/68G01N30/6078G01N2030/045
Inventor 王学瑞陈方露令狐智熊娟郑波邹春兰刘强
Owner YAOPHARMA CO LTD
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