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Method for measuring content of related substances in bosentan or preparation of bosentan

A method of determination and technology of related substances, applied in the field of detection of related substances and content, can solve problems such as difficult separation and many impurities in intermediates, and achieve the effect of improving basis, strong operability and strong specificity

Active Publication Date: 2012-10-10
WUHAN WUYAO SCI & TECH
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Problems solved by technology

[0005] The detection method of related substances and content of bosentan and bosentan tablets has not been reported yet, and the difficulty of its determination method is that bosentan is a poorly water-soluble substance, and in the process of its synthesis, intermediates and produced There are many impurities, the properties are similar to those of bosentan, and it is difficult to separate

Method used

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  • Method for measuring content of related substances in bosentan or preparation of bosentan
  • Method for measuring content of related substances in bosentan or preparation of bosentan
  • Method for measuring content of related substances in bosentan or preparation of bosentan

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Experimental program
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Effect test

Embodiment 1

[0026] Embodiment 1 bosentan related substance determination

[0027] 1. Experimental equipment and chromatographic conditions

[0028] Shimadzu LC-10Atvp chromatographic instrument, Venusil MP C18 5μm4.6*250mm chromatographic column, mobile phase is acetonitrile-0.025mol / L sodium heptanesulfonate solution (adjust pH to 3.0 with phosphoric acid) (60:40)~(70 : 30); detection wavelength: 212 ~ 222nm; flow rate: 0.8ml / min ~ 1.2ml / min; the concentration of the prepared sample is about 0.1 ~ 1.0mg / ml; injection volume: 5 ~ 200ul.

[0029] 2. Reagents

[0030] Sodium Heptane Sulfonate (HPLC Grade), Phosphoric Acid (AR Grade), Acetonitrile (HPLC Grade).

[0031] 3. Selection of chromatographic conditions

[0032] (1) mobile phase

[0033] We compared the chromatograms of the mobile phase with acetonitrile-0.05mol / L ammonium acetate solution and acetonitrile-0.025mol / L sodium heptanesulfonate solution (adjusted pH to 3.0 with phosphoric acid) by experiments, and acetonitrile-0.05 ...

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Abstract

The invention relates to a method for measuring content of related substances in bosentan or preparation of bosentan. The method is a high performance liquid chromatography, wherein the chromatographic column: octadecyl silane serves as the filler; the moving phase: acetonitrile-0.025mol / L sodium heptanesulfonate solution (regulating the PH to be 3.0 through phosphoric acid); the volume ratio of the acetonitrile and the sodium heptanesulfonate solution is (60:40)-(70-30); and the detection wavelength is 212-222nm. By means of the high performance liquid chromatography, content of samples, intermediates and impurities can be accurately measured simultaneously. The samples are thoroughly separated in the analyzing process, the analyzing results are good in reproducibility, and the method simply and reliably ensures quality control and sample quality in the production process.

Description

technical field [0001] The invention relates to a method for detecting medicines, in particular to a method for detecting related substances and contents of bosentan and its preparations. Background technique [0002] Bosentan, whose chemical name is 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methyl-phenoxy)-[2,2' ]-dipyrimidin-4-yl]-benzenesulfonamide monohydrate. Its structural formula is: [0003] [0004] Bosentan is a specific, competitive dual endothelin receptor blocker with affinity for both ETA and ETB receptors, with a slightly higher affinity for ETA receptors than for ETB receptors. It can reduce blood vessel pressure, prevent heart and blood vessel proliferation, reduce pulmonary fibrosis and inflammation, and is clinically used to treat patients with pulmonary arterial hypertension who have dyspnea symptoms during rest or light exercise, as well as to improve exercise tolerance and related symptoms. U.S. FDA on November 20, 2001 approved the listing of bos...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 付友珍乔春莲耿海明杨波冯小路郭婷婷
Owner WUHAN WUYAO SCI & TECH
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