Synthesis and Characterization of Impurities Listed in United States Pharmacopeia of Risperidone Tablets

Authors

  • Laki Magar  Department of chemistry, New Arts, Commerce and Science college, Ahmednagar, Maharashtra, India
  • Bhaskar H. Zaware  IPCA Laboratories Ltd. Chemical Research Division, Kandivali Industrial Estate,Kandivali (West). Mumbai, Maharashtra, India
  • Brajesh Sharma  
  • Kishor R. More  
  • Kailas Shikhare  
  • Leena Gupta  

Keywords:

Risperidone N-oxide, Bicyclorisperidone, Impurities, Synthesis.

Abstract

A very simple and efficient synthesis of three impurities of Risperidone tablets named Risperidone-cis-N-oxide, Risperidone-trans-N-oxide and Bicyclorisperidone mentioned in Unites States Pharmacopeia (USP) of Risperidone tablets has been presented in this manuscript. These three impurities were synthesized and fully characterized on the basis of mass, proton and carbon spectra.

References

  1. Reynolds, G. P. Ther. Adv. Psychopharmacol. 2011, 1, 197-204.
  2. He, H.; Richardson, J. S.International Clinical Psychopharmacology, 1995, 10, 19-30.
  3. Marder, S. R.; Meibach, R. C. Am. J. Psychiatry. 1994, 151, 825-35.
  4. Miyamoto, S.; G E Duncan, G. E.; Marx, C. E.; Lieberman, J. A. Molecular Psychiatry, 2005, 10, 79–104.
  5. Paul, S. M.; Mytelka, D. S.; Christopher T. Dunwiddie, C. T.; Persinger, C. C.; Munos, B. H.; , Lindborg, S. R.; Schacht, A. L. Nature Reviews Drug Discovery, 2010,9, 203-214.
  6. Holm, R.; Elder, D. P. ‎Eur. J. Pharm. Sci. 2016, 87, 118-135.
  7. International Conference on Harmonisation, ICH (2006) Q3B (R2): Impurities in new drug product.
  8. International Conference on Harmonisation, ICH (2005) Q2B (R1): Validation of analytical procedures: Text and methodology.
  9. USP monograph: Risperidone Tablets, USP38-NF33, Pharmacopeial forum, 32(4), 1109.
  10. Raymond, C. F. Jones.; Chatterley, A.; Marty, R.; Owton, W. M.; Mark, R. J. Elsegood, Chem. Commun., 2015, 51, 1112-1115.
  11. J. J. Li, Name Reactions, 4th ed., 2009, 62-63.

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Published

2018-01-22

Issue

Section

Research Articles

How to Cite

[1]
Laki Magar, Bhaskar H. Zaware, Brajesh Sharma, Kishor R. More, Kailas Shikhare, Leena Gupta, " Synthesis and Characterization of Impurities Listed in United States Pharmacopeia of Risperidone Tablets, International Journal of Scientific Research in Science, Engineering and Technology(IJSRSET), Print ISSN : 2395-1990, Online ISSN : 2394-4099, Volume 4, Issue 3, pp.19-22, January-February-2018.