Patent · US Active

Dexrazoxane analytical method

US11187683B2 · kind B2 · utility

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1References
15Claims
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Key dates

Filing dateNov 30, 2017
Grant dateNov 30, 2021
Priority date
Expiry dateJun 18, 2038

Classification

  • Technology area (CPC G)Physics
  • CPC primaryG01N2030/8809
  • WIPO fieldMeasurement
  • WIPO sectorInstruments

Abstract

A high performance liquid chromatography method used for dexrazoxane-related substances is provided, and in the method, a low-density bonding reversed-phase C18 chromatographic column resistant to pure water is employed; a gradient elution is carried out with mobile phase A and mobile phase B as eluents, the mobile phase A being a buffer, and the mobile phase B being an organic solvent; the volume percent of mobile phase A in eluents in a first stage of the gradient elution is not lower than 90%, and the duration of the first stage of the gradient elution ranges from 15˜30 minutes. By means of the analytical method, dexrazoxane is effectively separated from main impurities, and the qualities of the active pharmaceutical ingredients of dexrazoxane and the preparations thereof could be better controlled.

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