International E-publication: Publish Projects, Dissertation, Theses, Books, Souvenir, Conference Proceeding with ISBN.  International E-Bulletin: Information/News regarding: Academics and Research

Spectrophotometric Determination of Ibutilide Fumarate in Bulk Drug substance form

Author Affiliations

  • 1SAP Limited, Hyderabad, INDIA

Res.J.chem.sci., Volume 1, Issue (2), Pages 123-127, May,18 (2011)

Abstract

A simple and cost effective spectrophotometric method is described for the determination of Ibutilide fumarate in bulk drug substance form. The method is based on ‘complex formation’ concept under acidic conditions with acid dyes e.g. TPOOO. The colored species have absorption maxima at 485nm and obeys Beer’s law in the concentration range of 2.5 – 20 g mL-1. The absorbance was found to be increasing linearly with increasing concentration of Ibutilide, which is corroborated by the calculated correlation coefficient value of 0.9995 (n=8). The molar absorptivity and Sandell’s sensitivity are 3.611x104 1 mole cm-1 and 0.024 g cm-2 respectively. The slope and intercept of equation of regression line are 0.0403 and 0.0144 respectively. The limit of detection was 0.561 g mL-1 The optimum experimental parameters for the reaction were studied and also validity of the described procedure was assessed. The statistical analysis of results revealed high accuracy and good precision. The proposed method was successfully applied to the determination of Ibutilide Active Pharmaceutical Ingredient (API) in bulk drug substance form.

References

  1. Li Hong, Yu Zixun, Yue Changlin, Liu Xinhong, Zhu Yanan, Method for manufacturing ibutilide fumarate freeze-dried powder injection with high stability,Faming Zhuanli Shenqing Gongkai Shuomingshu, (2007)
  2. Xia Min, Zhang Tongxiang, Nasal formulations containing ibutilide for the treatment of arrhythmia Faming Zhuanli Shenqing Gongkai Shuomingshu, 11 (2005)
  3. Hsu C. L., and Walters, Chiral separation of ibutilide enantiomers by derivatization with 1-naphthyl isocyanate and high-performance liquid chromatography on a Pirkle column, R. R., Journal of Chromatography,550(1-2), I621-8(1991)
  4. Li Hong, Yue Changliln and Sun Bin, Method for preparation of Ibutilide fumarate, Faming Zhuanli Shenqing Gongkai Shuomingshu 13 (2006)
  5. Perricone Sam C., Chidester Constance G. and Hester Jackson B., Synthesis of (R)-N-[4-[4-(dibutylamino)-1-hydroxybutyl]phenyl]methanesulfonamide, (E)-2-butenedioate (2:1) salt (artilide fumarate) and the enantiomers of N-[4-[4-(ethylheptylamino)-1-hydroxybutyl]phenyl] methanesulfonamide, (E)-2-butenedioate (2:1) salt (ibutilide fumarate),TetrahedronAssymetry, 7(3), 677-90 (1996)
  6. Knobloch Karten, Brendel Joachim, Rosenstein Bjoern, Bleich Markus, Busch Andreas E. and Wirth Klaus J., Atrial-selective antiarrhythmic actions of novel Ikur vs. Ikr, Iks, and IKAch class Ic drugs and beta blockers in pigs,Medical sciences monitor,10(7) BR221-BR228 (2004)
  7. Hester Jackson B., Gibson John K., Buchanan Lewis V., Cimini Madelilne G., Clark Michael A., Emmert D. Edward, Glavanovich Michael A., Imbordino Rick J., Lemay Richelle J., McMillan Moses W., Perricone Salvatore C., Squires Donald M. and Walters Rodney R., Progress toward the Development of a Safe and Effective Agent for Treating Reentrant Cardiac Arrhythmias: Synthesis and Evaluation of Ibutilide Analogues with Enhanced Metabolic Stability and Diminished Proarrhythmic Potential, Journal of Medicinal chemistry, 44(7), 1099-1115 (2001)
  8. Oral Hakan., Electrical cardioversion of atrial fibrillation with ibutilide pretreatment,Cardiovascular Reviews and Reports, 21(4), 200-202 (2000)
  9. Vander Lugt, James T., Mattioni Thomas, Denker Stephen, Torchiana David, Ahern Thomas, Wakefield Linda K., Perry Kimberly T., Kowey Peter R., Efficacy and safety of ibutilide fumarate for the conversion of atrial arrhythmias after cardiac surgery,Lippincott Williams and Wilkins,100(4), 369-375 (1999)
  10. Robinson Casey, Robinson Ken, Castaner J., Ibutilide fumarate, Class III antiarrhythmic, Corvert, U-70226E,Drugs of the Future, 21(9), 894-900 (1996)
  11. Cimini Madeline G., Brunden Marshall N., Gibson J., Kenneth., Effects of ibutilide fumarate, a novel antiarrhythmic agent, and its enantiomers on isolated rabbit myocardium, European Journal of Pharmacology,222(1), 93-98 (1992)