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Measuring method of content of butyric acid clevidipine butyrate and content of related substances

A technology for clevidipine butyrate and related substances, which is applied in the field of determination of clevidipine butyrate content and related substances, can solve the problems of not being suitable for industrialization, demanding mobile phase requirements, unpopular analysis and detection, etc. Good performance, good repeatability and high feasibility

Inactive Publication Date: 2013-06-05
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Olle Gyllenhaal et al reported the purity of clevidipine by packed column supercritical fluid chromatography in JChromatogr A.1999 Nov 5; 862 (1): 95-104, but this method has stricter requirements on mobile phase , the equipment requirements are high, and the more important application of supercritical fluid chromatography is for separation and preparation. The application in analysis and detection has not yet been popularized, and it is not suitable for industrialization.
In the existing literature reports, there is no other report on the determination method of clevidipine butyrate content and related substances

Method used

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  • Measuring method of content of butyric acid clevidipine butyrate and content of related substances
  • Measuring method of content of butyric acid clevidipine butyrate and content of related substances
  • Measuring method of content of butyric acid clevidipine butyrate and content of related substances

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Experimental program
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Effect test

Embodiment 1

[0045] Chromatographic conditions:

[0046] High performance liquid chromatography: Waters-2489-2695

[0047] Detector: UV detector Detection wavelength: 240nm

[0048] Injection volume: 20.0μl Column temperature: 30℃

[0049] Flow rate: 1ml / min Column pressure: 1250psi

[0050] Chromatographic column: Agilent, C18, 5μm, 4.6×250mm

[0051] Analytical balance: 1 / 100,000, Sartorius BS21S

[0052] Mobile phase: acetonitrile: water = 70:30

[0053] The measurement results( figure 1 ):

[0054] name

Embodiment 2

[0056] Chromatographic conditions:

[0057] High performance liquid chromatography: Waters-2489-2695

[0058] Detector: UV detector Detection wavelength: 230nm

[0059] Injection volume: 20.0μl Column temperature: 50℃

[0060] Flow rate: 1ml / min Column pressure: 1250psi

[0061] Chromatographic column: Agilent, C18, 5μm, 4.6×250mm

[0062] Analytical balance: 1 / 100,000, Sartorius BS21S

[0063] Mobile phase: acetonitrile: water = 50:50

[0064] The measurement results( figure 2 ):

[0065] name

Embodiment 3

[0067] Chromatographic conditions:

[0068] High performance liquid chromatography: Waters-2489-2695

[0069] Detector: UV detector Detection wavelength: 239nm

[0070] Injection volume: 20.0μl Column temperature: 30℃

[0071]Flow rate: 1ml / min Column pressure: 1250psi

[0072] Chromatographic column: Agilent, C18, 5μm, 4.6×250mm

[0073] Analytical balance: 1 / 100,000, Sartorius BS21S

[0074] Mobile phase: acetonitrile: water = 60: 40

[0075] The measurement results( image 3 ):

[0076] name

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Abstract

Disclosed is a measuring method of the content of butyric acid clevidipine butyrate and the content of related substances. A high performance liquid chromatography is adopted, and octadecyl silane bonded silica gel is used as a reversed phase column of filler; ultraviolet detection is adopted, and detection wavelength is 230-250 nm; and a mobile phase A is acetonitrile, a mobile phase B is water, and the volume of the phase A accounts for 50%-90% of that of the mobile phases.

Description

Technical field: [0001] The invention relates to a method for determining the content of clevidipine butyrate and related substances. Background technique: [0002] Clevidipine (Clevidipine, CAS: 167221-71-8) has a chemical structural formula as follows: [0003] [0004] The chemical name is 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylic acid methyl (1-oxobutoxy) Methyl ester, a short-acting dihydropyridine calcium channel blocker. Clevidipine Butyrate Injection Emulsion was developed by AstraZeneca, the United Kingdom. The Medicines Company of the United States has its development and commercialization authorization in the global market except Japan, and this product was first listed in the United States in August 2008. The trade name is Cleviprex, which is used for the treatment of hypertensive patients who are not suitable for oral medicine or oral medicine is ineffective, and can also be used for the treatment of acute blood pressure rise ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/89
Inventor 田雪春陈立营李静
Owner TIANJIN JINYAO GRP
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