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Analysis method of rizatriptan benzoate raw material and tablet content

A technology of rizatriptan benzoate and an analysis method, which is applied in the field of content analysis of raw materials and tablets of rizatriptan benzoate for the treatment of migraine, can solve the problems of inability to completely separate, inability to accurately measure the content, triptan tailing and other problems, to ensure stability, prevent impurities from interfering with the main peak, and achieve the effect of simple implementation

Active Publication Date: 2016-07-06
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When the content of rizatriptan benzoate was determined by reversed-phase high performance liquid chromatography, the peaks of benzoic acid and rizatriptan could not be completely separated, the retention time was similar, and the tailing of rizatriptan was serious, so the content could not be accurately determined

Method used

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  • Analysis method of rizatriptan benzoate raw material and tablet content
  • Analysis method of rizatriptan benzoate raw material and tablet content
  • Analysis method of rizatriptan benzoate raw material and tablet content

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Effect test

Embodiment 1

[0030] High performance liquid chromatography: Agilent1200

[0031] Detector: UV detector Detection wavelength: 280nm

[0032] Injection volume: 20μl Column temperature: 30℃

[0033] Flow rate: 1ml / min Column: AgilentC18, 5μm, 4.6×250mm

[0034] Analytical balance: 1 / 100,000, SartoriusBS21S

[0035] Mobile phase: acetonitrile-sodium heptanesulfonate solution (take 4.045g of sodium heptanesulfonate, add appropriate amount of water to dissolve, add 4ml of phosphoric acid, add 8ml of glacial acetic acid, adjust the pH value to 3.0 with triethylamine, add water to dilute to 1000ml, Shake well) (20:80) as the mobile phase.

Embodiment 2

[0037] High performance liquid chromatography: Agilent1200

[0038] Detector: UV detector Detection wavelength: 280nm

[0039] Injection volume: 20μl Column temperature: 30℃

[0040] Flow rate: 1ml / min Column: AgilentC18, 5μm, 4.6×250mm

[0041] Analytical balance: 1 / 100,000, SartoriusBS21S

[0042] Mobile phase: acetonitrile-sodium heptanesulfonate solution (take 4.045g of sodium heptanesulfonate, add appropriate amount of water to dissolve, add 4ml of phosphoric acid, add 4ml of glacial acetic acid, adjust the pH value to 3.0 with triethylamine, add water to dilute to 1000ml, Shake well) (20:80) as the mobile phase.

Embodiment 3

[0044] High performance liquid chromatography: Agilent1200

[0045] Detector: UV detector Detection wavelength: 280nm

[0046] Injection volume: 20μl Column temperature: 30℃

[0047] Flow rate: 1ml / min Column: AgilentC18, 5μm, 4.6×250mm

[0048] Analytical balance: 1 / 100,000, SartoriusBS21S

[0049] Mobile phase: acetonitrile-sodium heptanesulfonate solution (take 4.045g of sodium heptanesulfonate, add appropriate amount of water to dissolve, add 4ml of phosphoric acid, add 12.0ml of glacial acetic acid, adjust the pH value to 3.0 with triethylamine, add water to dilute to 1000ml , shake well) (20:80) as the mobile phase.

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Abstract

A rizatriptan benzoate raw material and tablet content analysis method is characterized in that an octadecylsilane chemically bonded silica is adopted as a filler; a mobile phase is composed of a mobile phase A and a mobile phase B, the mobile phase A is acetonitrile, and the mobile phase B is an aqueous solution of sodium 1-heptanesulfonate with the pH value of 2.5-3.5, and a volume ratio of the mobile phase A to the of the mobile phase B is 20:80; and an UV detector is adopted to detect, and the detection wavelength is 280nm.

Description

Technical field: [0001] The present invention relates to the content analysis method of rizatriptan benzoate raw material and tablet of migraine treatment medicine, especially relates to the content analysis method of rizatriptan benzoate raw material and tablet by using the reverse phase ion-pair high performance liquid chromatography analyze. Background technique: [0002] Migraine is a chronic and debilitating disease that seriously affects the quality of life of patients. Its infestation of the total population has reached 5% to 17%, and women are usually 3 to 4 times higher than men. Serotonin 1 (5-HT1) receptor agonists are a class of drugs for the treatment of moderate to severe acute migraine attacks. Among them, Rizatriptan benzoate (Rizatriptan benzoate) is the second generation 5-HT receptor agonist developed by Merck Company of the United States, which was approved for marketing on June 29, 1998. The dosage form is tablet, the specification is 5mg, 10mg. Clin...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 郭志强李静
Owner TIANJIN JINYAO GRP