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Bupropion Hydrochloride.

S R Khan1, R T Berendt1, C D Ellison1

  • 1Division of Product Quality Research, US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Testing and Research, Silver Spring, MD, United States.

Profiles of Drug Substances, Excipients, and Related Methodology
|March 5, 2016
PubMed
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This study details the comprehensive chemical and analytical profile of bupropion hydrochloride, a unique antidepressant. It covers spectroscopic data, stability, and biological properties for bupropion, aiding in its understanding and application.

Area of Science:

  • Analytical Chemistry
  • Pharmacology
  • Organic Chemistry

Background:

  • Bupropion hydrochloride is a norepinephrine-dopamine disinhibitor (NDDI) used for depression and smoking cessation.
  • It is structurally unique among antidepressants, lacking direct action on the serotonin system.
  • Understanding its comprehensive profile is crucial for its therapeutic applications.

Purpose of the Study:

  • To present a comprehensive chemical, physical, and spectroscopic profile of bupropion hydrochloride.
  • To detail analytical methodologies for bupropion and its related impurities/metabolites.
  • To provide an overview of its biological properties, including toxicity, metabolism, and pharmacokinetics.

Main Methods:

  • Extensive spectroscopic analysis: mass spectrometry, 1D/2D NMR, solid-state NMR, IR, NIR, Raman, UV, X-ray diffraction.
Keywords:
AminoketoneAntidepressantBupropion hydrochlorideNorepinephrine-dopamine disinhibitor and stability

Related Experiment Videos

  • Wet chemistry studies: pH, solubility, solution, and plasma stability.
  • Chromatographic methods: High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC).

    • Main Results:

    • A detailed spectroscopic and physical characterization of bupropion hydrochloride was established.
    • Stability studies in various conditions and analytical methods for quantification were presented.
    • Key biological properties, including toxicity and pharmacokinetics, were summarized.

    Conclusions:

    • The study provides a thorough analytical and biological profile of bupropion hydrochloride.
    • This comprehensive data supports further research and development of bupropion.
    • The presented methodologies are valuable for quality control and understanding bupropion's behavior.