Method for detecting related substances in flurbiprofen axetil drug

A technology of flurbiprofen axetil and a detection method, applied in the field of medicine, can solve the problems such as peak separation not meeting requirements, baseline drift and the like

Active Publication Date: 2020-01-03
YANGTZE RIVER PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Chinese patent application CN106770807A discloses a method for detecting related substances in flurbiprofen axetil injection. The application adopts reverse high performance liquid chromatography with glacial acetic acid-acetonitrile-water as mobile phase and can separate flurbiprofen axetil through gradient elution. Two pairs of enantiomers of flurbiprofen axetil in profen axetil injection, in addition, the application discloses that when using a mobile phase containing methanol or ethanol to detect flurbiprofen axetil, adjust the concentration of methanol or ethanol Ratio In liquid chromatography, the peak resolution of the two pairs of enantiomers cannot meet the requirements, and there will be baseline drift
Deflurbiprofen axetil also has two pairs of enantiomers. At present, there are no several detection methods that can separate and detect the two pairs of enantiomers of flurbiprofen axetil and deflurbiprofen axetil at the same time. Two pairs of enantiomers of esters

Method used

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  • Method for detecting related substances in flurbiprofen axetil drug
  • Method for detecting related substances in flurbiprofen axetil drug
  • Method for detecting related substances in flurbiprofen axetil drug

Examples

Experimental program
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Effect test

Embodiment 1

[0031] Chromatographic conditions

[0032] Chromatograph model: Agilent 1260,

[0033] The column is Kinetex F5 (4.6×250mm, 5μm),

[0034] Mobile phase: acetonitrile: water-40:60 (volume ratio) isocratic elution,

[0035] Detection wavelength: 254nm,

[0036] Column temperature: 50°C,

[0037] Flow rate: 1ml / min.

[0038] Preparation of the test solution

[0039] Get flurbiprofen axetil injection 1ml (equivalent to flurbiprofen axetil 10mg), be placed in 20ml volumetric flask, add mobile phase and dilute to scale, shake up, as need testing solution. According to the above chromatographic conditions, measure 20 μL and inject it into the liquid chromatograph, record the chromatogram, see the chromatogram figure 1 , the results are shown in the table below:

[0040]

[0041]

[0042] Under this chromatographic condition, the baseline is smooth. No. 1 peak (retention time 39.354min) and No. 2 peak (retention time 41.764min) are two pairs of enantiomers of deflurbip...

Embodiment 2

[0044] Chromatographic conditions

[0045] Chromatograph model: Waters e2695,

[0046] The column is Kinetex F5 (4.6×250mm, 5μm),

[0047] Mobile phase: acetonitrile: water-42:58 (volume ratio) isocratic elution,

[0048] Detection wavelength: 254nm,

[0049] Column temperature: 45°C,

[0050] Flow rate: 1.0ml / min.

[0051] Preparation of the test solution

[0052] Get flurbiprofen axetil injection 1ml (equivalent to flurbiprofen axetil 10mg), be placed in 20ml volumetric flask, add dehydrated alcohol and dilute to scale, shake up, as need testing solution. According to the above chromatographic conditions, measure 20 μL and inject it into the liquid chromatograph, record the chromatogram, see the chromatogram figure 2 , the results are shown in the table below:

[0053] Peak ID retention time (min) %area Separation 1 33.856 0.130 21.92 2 35.814 0.119 2.07 3 37.864 45.658 2.00 4 39.972 53.942 1.83

[0054]Under this ch...

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Abstract

The invention discloses a method for detecting related substances in a flurbiprofen axetil drug. A high performance liquid chromatography is adopted, and the mobile phase is a mixed solution of acetonitrile and water. According to the detection method provided by the invention, two pairs of enantiomers of flurbiprofen axetil and two pairs of enantiomers of defluorinated flurbiprofen axetil can beseparated synchronously.

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 medicines. Background technique [0002] Flurbiprofen axetil injection is a non-steroidal analgesic with lipid microspheres as the drug carrier. After the drug enters the body and distributes to wounds and tumors, it releases flurbiprofen axetil from the lipid microspheres, and is rapidly hydrolyzed to flurbiprofen under the action of carboxyl esterase. Flurbiprofen inhibits arachidonic acid Cyclooxygenase activity, thereby inhibiting the synthesis of prostaglandins that cause pain and inflammatory reactions, and play an analgesic effect. It is widely used clinically. It has analgesic, anti-inflammatory and antipyretic effects, and can be used for analgesia after surgery and various cancers. Flurbiprofen axetil is the prodrug of flurbiprofen, its chemical name is (±)-2-(2-fluoro-4-biphenyl) propionate-1-acetoxyet...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/34
CPCG01N30/02G01N30/34G01N2030/047
Inventor 常静宇吕慧敏张海波肖雨王德国
Owner YANGTZE RIVER PHARM GRP CO LTD
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