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Method for detecting briracetam and an isomer thereof

A detection method and isomer technology, applied in the field of analytical chemistry, can solve problems such as flipping, and achieve the effects of good specificity and repeatability, high sensitivity, and accurate and reliable inspection results

Pending Publication Date: 2021-05-25
HANGZHOU HEZE PHARMA TECH +1
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] This compound has two chiral centers, and under conditions such as high temperature or light, it may cause the inversion of the chiral centers, thereby introducing three isomer impurities

Method used

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  • Method for detecting briracetam and an isomer thereof
  • Method for detecting briracetam and an isomer thereof
  • Method for detecting briracetam and an isomer thereof

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Embodiment Construction

[0036] Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings. The experimental methods not indicating specific conditions in the preferred embodiments are generally in accordance with conventional conditions, and the given examples are to better illustrate the content of the present invention, but the content of the present invention is not limited to the given examples. Therefore, non-essential improvements and adjustments to the implementation by those skilled in the art based on the content of the invention above still fall within the protection scope of the present invention.

[0037] Test 1:

[0038] Instrument: Diane U3000

[0039] Chromatographic column: Chiralpak AD-H, 4.6mm×250mm, 5μm or a column with equivalent performance

[0040] Mobile phase: n-hexane-isopropanol (90:10)

[0041] Flow rate: 1.0ml / min

[0042] Column temperature: 20°C

[0043] Detector: UV

[0044] Detection wavelen...

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Abstract

The invention relates to a method for detecting briracetam and an isomer thereof, which comprises a step of detecting by adopting a high performance liquid chromatography, and the liquid chromatography conditions are as follows: silica gel coated with amylose-tri (3, 5-dimethylphenyl carbamate) on the surface is used as a filling agent; and a mixed solution of n-hexane, isopropanol and organic base is used as a mobile phase, and the mobile phase enters a detector for detection. The method can effectively separate and measure the contents of the enantiomers and diastereoisomers of the briracetam, is simple and convenient to operate, high in sensitivity, good in specificity and repeatability, accurate and reliable in detection result, and has very important significance for realizing quality control of the briracetam and preparations thereof, and the solvent peak does not interfere with the measurement in the detection process.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a detection method for brivaracetam and its isomers. Background technique [0002] The molecular formula of Brivaracetam is C11H20N2O2, the English name is Brivaracetam, the CAS number is 357336-20-0, and the structural formula is shown in Formula IV. It is a second-generation antiepileptic drug developed by UCB Company in Belgium, and its trade name is Briviact®. For the treatment of partial-onset epilepsy patients 16 years of age and older, adjuvant therapy with or without secondary generalized seizures. [0003] [0004] Formula Ⅳ: Briracetam [0005] The compound has two chiral centers, which may cause inversion of the chiral centers under conditions such as high temperature or light, thereby introducing three isomer impurities. Since the main active ingredient that works is brivaracetam, and the increase in the content of isomer impurities will reduce the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/884
Inventor 倪晟夏金强叶艳蓉王菲周亮赵航徐兵勇陈鸿翔姜维斌屠芳芳卜华荣戴寿沣汤丽玲
Owner HANGZHOU HEZE PHARMA TECH
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