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Synthesis and Characterization of Potential and Degraded Impurities of Regadenoson

Author(s):

Singaram Sathiyanarayanan*, C.S Venkatesan and Senthamaraikannan Kabilan   Pages 1 - 10 ( 10 )

Abstract:


Background: Regadenoson is an A2A adenosine receptor agonist that is a coronary vasodilator and commonly used as a pharmacologic cardiac stressing agents. Method: 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. Result: 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.

Keywords:

Regadenoson, Potential impurities, ICH guidelines, IR, Mass and NMR

Affiliation:

Department of Chemistry, Faculty of Science, Annamalai University, Annamalai Nagar, Tamil Nadu 608002, Gland Pharma Ltd, Research and Development, D.P.Pally, Hyderabad 500 043, Department of Chemistry, Faculty of Science, Annamalai University, Annamalai Nagar, Tamil Nadu 608002



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