2. Academic Validation
  3. Synthesis and characterization of new related substances of the antiarrhythmic drug dronedarone hydrochloride

Synthesis and characterization of new related substances of the antiarrhythmic drug dronedarone hydrochloride

  • J Pharm Biomed Anal. 2015 Oct 10;114:441-6. doi: 10.1016/j.jpba.2015.06.026.
Marina Santos 1,  Lia C García 2,  Cintia Checura 1,  Lucía Gandolfi Donadío 2,  Carlos Fernandez 3,  Hernán Orgueira 3,  Maria J Comin 4
Affiliations

Affiliations

  • 1 Laboratory of Analytical Research and Process Control, Center of Research and Development in Chemistry, National Institute of Industrial Technology, Buenos Aires, Argentina.
  • 2 Laboratory of Organic Synthesis, Center of Research and Development in Chemistry, National Institute of Industrial Technology, Buenos Aires, Argentina.
  • 3 MAPRIMED S.A., Av Directorio 6155, C1440ATA-CABA, Argentina.
  • 4 Laboratory of Organic Synthesis, Center of Research and Development in Chemistry, National Institute of Industrial Technology, Buenos Aires, Argentina. Electronic address: jcomin@inti.gob.ar.
PMID: 26133102 DOI: 10.1016/j.jpba.2015.06.026
Abstract

Two new potential impurities of antiarrhythmic drug substance Dronedarone Hydrochloride together with debutyldronedarone were detected by LC-MS analysis during process development. A successful synthetic strategy for the synthesis of these potential impurities was developed facilitating the access to new impurity Reference Standards. Their synthesis and characterization are discussed in detail. The availability of these impurity standards allowed cost reduction through the increase of process control.

Keywords

Antiarrhythmic drug; Dronedarone hydrochloride; Impurity profile; LC–MS; Related substances; Synthesis.

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