Detection method of related substance in flurbiprofen axetil injection

A technology of flurbiprofen axetil and a detection method, applied in the field of medicine, can solve the problems of large side effects, reducing the clinical dosage of flurbiprofen axetil and the like

Inactive Publication Date: 2017-05-31
天津蓝丹企业管理咨询合伙企业(有限合伙)
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  • Abstract
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Problems solved by technology

Patent CN102670502A discloses an injection emulsion with S(+)-flurbiprofen axetil as a medicinal active ingred...

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  • Detection method of related substance in flurbiprofen axetil injection

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Embodiment 1

[0020] Embodiment 1 Using the detection method of the present invention to detect flurbiprofen axetil injection

[0021] Chromatographic conditions

[0022] The chromatographic column is Symmetry shield RP18 (4.6×150mm, 3.5μm),

[0023] A: 0.15V / V glacial acetic acid, B: the mixed solution of acetonitrile: water=95:5 is the mobile phase, adopting the gradient elution mode; during the elution process, the volume percentage of mobile phase A and B is as follows:

[0024] 0-20min, A is 30%, B is 70%; 20-40min, A is increased from 30% to 60%, B is reduced from 70% to 40%; 40-56min, A is reduced from 60% to 30 %, B increased from 40% to 70% at a constant speed;

[0025] Preparation of the test solution

[0026] Get flurbiprofen axetil injection 1ml (equivalent to flurbiprofen axetil 10mg), put in 50ml volumetric flask, add acetonitrile and dilute to scale, shake up, as need testing solution. According to the above chromatographic conditions, measure 10 μL and inject it into the...

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Abstract

The invention provides a detection method of a related substance in flurbiprofen axetil injection. Two pairs of enantiomers and related substances thereof of the flurbiprofen axetil in the flurbiprofen axetil injection can be well separated by use of a reverse high performance liquid chromatography method after adopting gradient elution.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for detecting related substances in flurbiprofen axetil injection. Background technique [0002] Flurbiprofen is a non-steroidal anti-inflammatory drug with anti-inflammatory and analgesic effects. Flurbiprofen axetil is the prodrug of flurbiprofen, its chemical name is (±)-2-(2-fluoro-4-biphenyl)propionic acid-1-acetoxyethyl ester, and its structural formula is as follows Show. It is widely used clinically, and can be used for analgesia after surgery and various cancers. The mechanism of action is mainly to inhibit the activity of arachidonic acid epoxidase, thereby inhibiting the synthesis of prostaglandins in pain and inflammatory responses. [0003] [0004] Flurbiprofen axetil has two pairs of enantiomers. The current clinically used flurbiprofen axetil is its racemate. The preparation type is fat emulsion injection. This dosage form is developed based on the...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 不公告发明人
Owner 天津蓝丹企业管理咨询合伙企业(有限合伙)
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