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Original Articles

A VALIDATED STABILITY INDICATING UPLC METHOD FOR SIMULTANEOUS DETERMINATION OF ASSAY, RELATED SUBSTANCES, AND DEGRADATION PRODUCTS OF PALIPERIDONE PALMITATE ACTIVE PHARMACEUTICAL INGREDIENT AND ITS PHARMACEUTICAL INJECTION FORMS

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Pages 533-546 | Published online: 07 Feb 2012

REFERENCES

  • Bishara , D. Once Monthly Paliperidone Injection for the Treatment of Schizophrenia . Neuropsych, Dis, Treatment 2010 , 6 , 561 – 572 .
  • Hoy , S. M. ; Scott , L. J. ; Keating , G. M. Intramuscular Paliperidone palmitate . CNS Drugs 2010 , 24 , 227 – 244 .
  • Citrome , L. Paliperidone Palmitate – Review of the Efficacy, Safety and Cost of a New Second-Generation Depot Antipsychotic Medication . Int. J. Clin. Practice 2010 , 64 , 216 – 239 .
  • Swartz , M. E. UPLC: An Introduction and Review . J. Liq. Chromatogr. R. T. 2005 , 28 , 1253 – 1263 .
  • Santiago , I. ; Naama Chasid , N. ; Kobi Chen , K. ; Porter-kleks , O. Pure paliperidone and processes for preparing thereof, 13 November 2008, U.S Patent 0281100 2009 .
  • Koilpillai , J. P. ; Kulkarni , P. B. ; Kelkar , L. M. ; Kae , S. A. ; Potdar , S. G. ; Narwade , K. B. ; Khan , M. A. ; Thorat , J. R. A process for preparation of paliperidone intermediates, 29 Oct 2009, WIPO 130710 A2, 2009 .
  • Bartl , J. ; Picha , F. Paliperidone derivatives, 5 Feb 2009, U.S Patent 0036470 A1 2009 .
  • Santiago , I. ; Shmuely , Y. ; Porter-Kleks , O. ; Chen , K. ; Singer , C. Processes for the preparation and purification of paliperidone palmitate, 20 Aug 2009, U.S. patent 0209757 A1 2009 .
  • ICH Q1A (R2). Stability Testing of New Drug Substances and Products, USFDA-Federal Register, USA, 2003 .
  • ICH Q2 (R1). Validation of Analytical Procedures: Text and Methodology, USFDA-Federal Register, USA, 2005 .

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