Development and Validation of High Performance Liquid Chromatographic and UV-Derivative Spectrophotometric Methods for the Determination of Sotalol Hydrochloride in Tablets

REFERENCES

• Amin , A.S. , Ragab , G.H. , and Saleh , H. 2002 . Colorimetric determination of β-blockers in pharmaceutical formulations . J. Pharm. Biomed. Anal. , 30 : 1347 – 1353 .
   PubMed Web of Science ®Google Scholar
• Association of Official Analytical Chemist 1990 . Official Methods of Analysis, AOAC . Gaithersburg , MD : AOAC Press .
   Google Scholar
• Bartek , M.J. 1987 . Liquid chromatographic determination of sotalol in plasma and urine employing solid-phase extration and fluorescence detection . J. Chromatogr. , 421 : 309 – 318 .
   PubMedGoogle Scholar
• Boutagy , J. and Shenfield , G.M. 1991 . Simplified procedure for the determination of sotalol in plasma by high-performance liquid chromatography . J. Chromatogr. , 565 : 523 – 528 .
   PubMedGoogle Scholar
• Brunton , L.L. , Lazo , J.S. , and Parker , K.L. 2001 . Goodman & Gilman's The Pharmacological Basis of Therapeutics . New York : McGraw Hill .
   Google Scholar
• Chiap , P. , Ceccato , A. , Buraglia , B.M. , Boulanger , B. , Hubert , P. , and Crommen , J. 2001 . Development and validation of an automated method for the liquid chromatographic determination of sotalol in plasma using dialysis and trace enrichment on a cation-exchange pre-column as on-line sample preparation . J. Pharm. Biomed. Anal. , 24 : 801 – 814 .
   PubMed Web of Science ®Google Scholar
• Delamoye , M. , Duverneuil , C. , Paraire , F. , Mazancourt , P. , and Alvarez , J.C. 2004 . Simultaneous determination of thirteen β-blockers and one metabolite by gradient high-performance liquid chromatography with photodiode-array UV detection . Forensic Sci. Int. , 141 : 23 – 31 .
   PubMed Web of Science ®Google Scholar
• Erram , S.V. , Tipnis , H.P. 1994 . Simple spectrometric analysis of sotalol hydrochloride and hydrochlorothiazide from combined pharmaceutical dosages . Indian Drugs , 31 : 16 – 20 .
   Google Scholar
• International Conference on Harmonization for Registration of Pharmaceuticals for Human Use (ICH) . 2005 . Validation of Analytical Procedures: Text and Methodology , Q2 (R1) .
   Google Scholar
• Kärkkäinen , S. 1984 . High-performance liquid chromatographic determination of sotalol in biological fluids . J. Chromatogr. , 336 : 313 – 319 .
   PubMed Web of Science ®Google Scholar
• Läer , S. , Wauer , I. , and Scholz , H. 2001 . Small blood volumes from children for quantitative sotalol determination using high-performance liquid chromatography . J. Chromatogr. B , 753 : 421 – 425 .
   PubMed Web of Science ®Google Scholar
• Liu , G. , Li , S. , Jia , J. , Liu , Y. , Pan , C. , Yu , C. , Cai , Y. , and Ren , J. 2007 . Simultaneous determination of ten antiarrhythmic drugs and a metabolite in human plasma by liquid chromatography-tandem mass spectrometry . J. Chromatogr. B , 847 : 174 – 181 .
   PubMedGoogle Scholar
• Martindale The Complete Drug Reference . 2002 . London : Pharmaceutical Press .
   Google Scholar
• Ranta , V.P. , Toropainen , E. , Talvitie , A. , Auriola , S. , and Urtti , A. 2002 . Simultaneous determination of eight β-blockers by gradient high-performance liquid chromatography with combined ultraviolet and fluorescence detection in corneal permeability studies in vitro . J. Chromatogr. B , 772 : 81 – 87 .
   PubMed Web of Science ®Google Scholar
• Rbeida , O. , Christiaens , B. , Chiap , P. , Hubert , P. , Lubda , D. , Boss , K.S. , and Crommen , J. 2003 . Fully automated LC method for the determination of sotalol in human plasma using restricted access material with cation exchange properties for sample clean-up . J. Pharm. Biomed. Anal. , 32 : 829 – 838 .
   PubMed Web of Science ®Google Scholar
• Sallustio , B.C. and Morris , R.G. 1992. High-performance liquid chromatographic determination of sotalol in plasma. J. Chromatogr. , 576: 321–327.
   PubMedGoogle Scholar
• Santos , S.R. , Papini , O. , Omosako , C.E. , Pereira , M.D. , Quintavalle , T.B.G. , Riccio , M.F. , Kurata , A. , Pereira , V.A. , and Pietro , G. 2000 . A simple HPLC fluorescence method for the measurement of R,S-sotalol in the plasma of patients with life-threatening cardiac arrhythmias . Braz. J. Med. Biol. Res. , 33 : 199 – 204 .
   PubMedGoogle Scholar
• Sweetman , S.C. Martindale. The complete drug reference . 2002 . London : Pharmaceutical Press .
   Google Scholar
• United States Pharmacopeia. 31st ed. 2008 . Rockville , MD : The United States Pharmacopeial Convention, Inc. ; 3264 – 3265 .
   Google Scholar