Title:Synthesis and Characterization of Potential and Degraded Impurities of Regadenoson
Volume: 16
Issue: 8
Author(s): Singaram Sathiyanarayanan*, Chidambaram Subramanian Venkatesan and Senthamaraikannan Kabilan
Affiliation:
- Department of Chemistry, Faculty of Science, Annamalai University, Annamalai Nagar, Tamil Nadu 608002,India
Keywords:
Regadenoson, potential impurities, ICH guidelines, IR, mass, NMR, degradation products.
Abstract:
Background: Regadenoson is an A2A adenosine receptor agonist that is a coronary vasodilator
and commonly used as a pharmacologic cardiac stressing agents.
Methods: HPLC method was used for the analysis of related substances. The degraded impurities during
the process were isolated and characterized by IR, Mass and NMR spectral analysis.
Results: Forced degradation study of regadenoson under conditions of hydrolysis (neutral, acidic and
alkaline) and oxidations suggested in the ICH Q1A(R2) was accomplished. The drug showed significant
degradation under all the above conditions. On the whole, five novel degradation products were found
under diverse conditions along with process related impurities which were not reported earlier.
Conclusion: All the degradation products were well characterized by using advanced spectroscopic techniques
like IR, 1H NMR, 13C NMR and Mass spectra. The identification of these impurities will be productive
for the quality control during the production and stability behavior of the regadenoson drug substance.
