LC and LC-MS Evaluation of Stress Degradation Behavior of Carvedilol

REFERENCES

• Abshagen , U.J. Novel effect of carvedilol on Ca2+ movement in renal tubular cells . Cardiovasc. Pharmacol. 1987 , 10 , S23 – S32 .
   Google Scholar
• International Conferences on Harmonization of the Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidance for Industry Q1A(R2) Stability Testing of New Drug Substances and Products , 2003 .
   Google Scholar
• Cong-Jun , L. ; Kari , P.U. ; Noecker , L.A. ; Jones , S.R. ; Sabo , A.M. , McCormick , T.J. ; Johnston , S.M. Determination of degradation products of squalamine lactate . J. Pharm. Biomed. Anal. 2003 , 32 , 85 – 96 .
   PubMedGoogle Scholar
• Imran , M. ; Singh , R.S.P. ; Chandran , S. Stability indicating ultraviolet spectroscopic method for the estimation of ezetimibe and carvedilol . Pharmazie. 2006 , 61 , 766 – 769 .
   PubMed Web of Science ®Google Scholar
• Stojanovic , J. ; Marinkovic , V. ; Vladimirov , S. ; Velickovic , D. ; Sibinovic , P. Determination of carvedilol and its Impurities in Pharmaceuticals. Chromatographia. 2005, 62, 539–542.
   Google Scholar
• Stojanovic , J. ; Vladimirov , S. ; Marinkovi , V. ; Velikovi , D. ; Sibinovi , P. Monitoring of the photochemical stability of carvedilol and its degradation products by the RP-HPLC method . J. Serb. Chem. Soc. 2007 , 72 , 37 – 44 .
   Web of Science ®Google Scholar
• Pokharkar , V.B. ; Mandpe , L.P. ; Padamwar , M.N. ; Ambike , A.A. ; Mahadik , K.R. ; Paradkar , A. Development, characterization and stabilization of amorphous form of a low Tg drug . Powder Technol. 2006 , 167 , 20 – 25 .
   Web of Science ®Google Scholar
• Gordon , S.G. ; Boothe , D.M. ; Gaudette , V.A. ; Miller , M.W. Stability of carvedilol in an oral liquid preparation . J. Vet. Intern. Med. 2006 , 20 , 795 – 795 .
   Google Scholar
• Agnihotri , S.A. ; Aminabhavi , T.M. Development of novel interpenetrating network gellan gum-poly (vinyl alcohol) hydrogel microspheres for the controlled release of carvedilol . Drug Devel. Ind. Pharm. 2005 , 31 , 491 – 503 .
   PubMed Web of Science ®Google Scholar
• Ieggli , C.V. Carvedilol – Desenvolvimento e validação de Métodos de Análise ; Dissertação de Mestrado. Universidade Federal de Santa Maria , 2005 , 93 .
   Google Scholar
• Ieggli , C.V.S. ; Cardoso , S.G. ; Belle , L.P. Validation of UV spectrophotometric and nonaqueous titration methods for the determination of carvedilol in pharmaceutical formulations . J. AOAC Intl. 2005 , 88 , 1299 – 1303 .
   PubMedGoogle Scholar
• Bakshi , M. ; Singh , S. Development of validated stability-indicating assay methods—critical review . J. Pharm. Biomed. Anal. 2002 , 28 , 1011 – 1040 .
   PubMed Web of Science ®Google Scholar
• International Conference on Harmonisation (ICH) of Technical Requirements for the Registration of Pharmaceutical for Human Use. Validation of Analytical Procedures: Methodology (ICH-Q2B), November, 2005 .
   Google Scholar
• Nudelman , N.S. Estabilidad de Medicamentos, El Ateneo, Buenos Aires, 1975 .
   Google Scholar
• Carstensen , J.T. ; Rhodes , C.T. Drug stability – Principles and practices, , Third Ed. ; Marcel-Dekker, Inc. : New York , 2000 .
   Google Scholar
• Brasil. Agência Nacional de Vigilância Sanitária. RE n° 1, de 29 de julho de 2005. Guia para a Realização de Estudos de Estabilidade. Diário Oficial da União, Brasília, 01 ago. 2005 .
   Google Scholar
• Brazilian Pharmacopeia, 4th Ed., 1988 .
   Google Scholar
• Borges , N.C.C. ; Mendes , G.D. ; Silva , D.O. ; Rezende , V.M. Barrientos-Astigarraga , R.E. ; De Nucci , G. Quantification of carvedilol in human plasma by high-performance liquid chromatography coupled to electrospray tandem mass spectrometry: Application to bioequivalence study . J. Chromatogr. B. 2005 , 822 , 253 – 262 .
   PubMedGoogle Scholar
• Czeskis , B.A. ; Wheeler , W.J. Synthesis of ß3 adrenergic receptor agonist LY377604 and its metabolite 4-hydroxycarbazole, labeled with carbon-14 and deuterium . J. Labelled Comp. Radiopharmaceut. 2005 , 48 , 407 – 419 .
   Google Scholar
• British Pharmacopoeia, International Edition, HMSO, London, 2007 .
   Google Scholar