Table of Contents
ISRN Analytical Chemistry
Volume 2012, Article ID 924185, 7 pages
http://dx.doi.org/10.5402/2012/924185
Research Article

Method Development and Validation for the Simultaneous Determination of Fexofenadine Hydrochloride and Montelukast Sodium in Drug Formulation Using Normal Phase High-Performance Thin-Layer Chromatography

Department of Pharmaceutical Chemistry, Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Erandwane, Pune, Maharashtra 411038, India

Received 23 February 2012; Accepted 15 March 2012

Academic Editors: P. Campíns-Falcó and T. Macko

Copyright © 2012 Suparna S. Tandulwadkar et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. A. Markham and A. J. Wagstaff, “Fexofenadine,” Drugs, vol. 55, no. 2, pp. 269–276, 1998. View at Publisher · View at Google Scholar · View at Scopus
  2. K. Simpson and B. Jarvis, “Fexofenadine: a review of its use in the management of seasonal allergic rhinitis and chronic idiopathic urticaria,” Drugs, vol. 59, no. 2, pp. 301–321, 2000. View at Google Scholar · View at Scopus
  3. E. Caballero, I. Ocaña, J. R. Azanza, and B. Sádaba, “Fexofenadine: a antihistaminic. review of its practical characteristics,” Revista de medicina de la Universidad de Navarra, vol. 43, no. 2, pp. 93–97, 1999. View at Google Scholar · View at Scopus
  4. D. K. Robbins, M. A. Castles, D. J. Pack, V. O. Bhargava, and S. J. Weir, “Dose proportionality and comparison of single and multiple dose pharmacokinetics of fexofenadine (MDL 16455) and its enantiomers in healthy male volunteers,” Biopharmaceutics and Drug Disposition, vol. 19, no. 7, pp. 455–463, 1998. View at Google Scholar
  5. M. J. O’Neil, The Merck Index: An Encyclopedia of Chemicals, Drugs and Biologicals, Merck and Co., Whitehouse station, NJ, USA, 14th edition, 2006.
  6. T. F. Reiss, P. Chervinsky, R. J. Dockhorn, S. Shingo, B. Seidenberg, and T. B. Edwards, “Montelukast, a once-daily leukotriene receptor antagonist, in the treatment of chronic asthma: a multicenter, randomized, double-blind trial,” Archives of Internal Medicine, vol. 158, no. 11, pp. 1213–1220, 1998. View at Publisher · View at Google Scholar · View at Scopus
  7. H. E. Claesson and S. E. Dahlén, “Asthma and leukotrienes: antileukotrienes as novel anti-asthmatic drugs,” Journal of Internal Medicine, vol. 245, no. 3, pp. 205–227, 1999. View at Publisher · View at Google Scholar · View at Scopus
  8. P. V. Polawar, U. D. Shivhare, K. P. Bhusari, and V. B. Mathur, “Development and validation of spectrophotometric method of analysis for fexofenadine HCl,” Research Journal of Pharmacy and Technology, vol. 1, no. 4, pp. 539–540, 2008. View at Google Scholar
  9. B. Narayana and K. Veena, “A new method for the spectrophotometric determination of fexofenadine hydrochloride,” Indian Journal of Chemical Technology, vol. 17, no. 5, pp. 386–390, 2010. View at Google Scholar · View at Scopus
  10. K. Suresh Kumar, V. Ravichandran, M. K. Mohan Maruga Raja, R. Thyagu, and A. Dharamsi, “Spectrophotometric determination of Fexofenadine hydrochloride,” Indian Journal of Pharmaceutical Sciences, vol. 68, no. 6, pp. 841–842, 2006. View at Google Scholar · View at Scopus
  11. R. M. Maggio, P. M. Castellano, S. E. Vignaduzzo, and T. S. Kaufman, “Alternative and improved method for the simultaneous determination of fexofenadine and pseudoephedrine in their combined tablet formulation,” Journal of Pharmaceutical and Biomedical Analysis, vol. 45, no. 5, pp. 804–810, 2007. View at Publisher · View at Google Scholar · View at Scopus
  12. T. Radhakrishna and G. Om Reddy, “Simultaneous determination of fexofenadine and its related compounds by HPLC,” Journal of Pharmaceutical and Biomedical Analysis, vol. 29, no. 4, pp. 681–690, 2002. View at Publisher · View at Google Scholar · View at Scopus
  13. S. Karakuş, I. Küçükgüzel, and S. G. Küçükgüzel, “Development and validation of a rapid RP-HPLC method for the determination of cetirizine or fexofenadine with pseudoephedrine in binary pharmaceutical dosage forms,” Journal of Pharmaceutical and Biomedical Analysis, vol. 46, no. 2, pp. 295–302, 2008. View at Publisher · View at Google Scholar · View at Scopus
  14. P. Solairaj, A. R. Bhat, S. G. Kini, R. Govindarajan, and R. Venkatraman, “HPTLC method for the estimation of fexofenadine HCL in tablet dosage form,” Indian Drugs, vol. 42, no. 7, pp. 424–427, 2005. View at Google Scholar · View at Scopus
  15. S. N. Meyyanathan, P. A. Shirsode, and B. Suresh, “Analysis of fexofenadine in pharmaceutical preparations by high performance thin layer chromatography,” Indian Drugs, vol. 42, no. 4, pp. 248–250, 2005. View at Google Scholar · View at Scopus
  16. M. Miura, T. Uno, T. Tateishi, and T. Suzuki, “Determination of fexofenadine enantiomers in human plasma with high-performance liquid chromatography,” Journal of Pharmaceutical and Biomedical Analysis, vol. 43, no. 2, pp. 741–745, 2007. View at Publisher · View at Google Scholar · View at Scopus
  17. T. Uno, N. Yasui-Furukori, T. Takahata, K. Sugawara, and T. Tateishi, “Liquid chromatographic determination of fexofenadine in human plasma with fluorescence detection,” Journal of Pharmaceutical and Biomedical Analysis, vol. 35, no. 4, pp. 937–942, 2004. View at Publisher · View at Google Scholar · View at Scopus
  18. M. S. Arayne, N. Sultana, H. Shehnaz, and A. Haider, “RP-HPLC method for the quantitative determination of fexofenadine hydrochloride in coated tablets and human serum,” Medicinal Chemistry Research, vol. 20, no. 1, pp. 55–61, 2011. View at Publisher · View at Google Scholar · View at Scopus
  19. W. Naidong, W. Z. Shou, T. Addison, S. Maleki, and X. Jiang, “Liquid chromatography/tandem mass spectrometric bioanalysis using normal-phase columns with aqueous/organic mobile phases—a novel approach of eliminating evaporation and reconstitution steps in 96-well SPE,” Rapid Communications in Mass Spectrometry, vol. 16, no. 20, pp. 1965–1975, 2002. View at Publisher · View at Google Scholar · View at Scopus
  20. M. Gergov, J. N. Robson, I. Ojanperä, O. P. Heinonen, and E. Vuori, “Simultaneous screening and quantitation of 18 antihistamine drugs in blood by liquid chromatography ionspray tandem mass spectrometry,” Forensic Science International, vol. 121, no. 1-2, pp. 108–115, 2001. View at Publisher · View at Google Scholar · View at Scopus
  21. I. Fu, E. J. Woolf, and B. K. Matuszewski, “Determination of fexofenadine in human plasma using 96-well solid phase extraction and HPLC with tandem mass spectrometric detection,” Journal of Pharmaceutical and Biomedical Analysis, vol. 35, no. 4, pp. 837–846, 2004. View at Publisher · View at Google Scholar · View at Scopus
  22. A. R. Breier, N. S. Nudelman, M. Steppe, and E. E. S. Schapoval, “Isolation and structure elucidation of photodegradation products of fexofenadine,” Journal of Pharmaceutical and Biomedical Analysis, vol. 46, no. 2, pp. 250–257, 2008. View at Publisher · View at Google Scholar · View at Scopus
  23. V. Pawar, S. Pai, and G. K. Roa, “Development and validation of UV spectrophotometric method for simultaneous estimation of montelukast sodium and bambuterol hydrochloride in bulk and tablet dosage formulation,” Jordan Journal of Pharmaceutical Sciences, vol. 1, no. 2, pp. 152–157, 2008. View at Google Scholar
  24. L. K. Garg, B. Ravi Kumar, S. S. Sait, and T. Krishnamurthy, “Determination of Montelukast Sodium in oral granules dosage forms by a simple and accurate UV spectrophotometric methods,” International Journal of Pharmaceutical Sciences Review and Research, vol. 7, no. 2, pp. 69–72, 2011. View at Google Scholar · View at Scopus
  25. I. Alsarra, N. Y. Khalil, M. Sultan, R. Al-Ashban, and F. Belal, “Spectrofluorometric determination of montelukast in dosage forms and spiked human plasma,” Pharmazie, vol. 60, no. 11, pp. 823–826, 2005. View at Google Scholar · View at Scopus
  26. A. S. Rathore, L. Sathiyanarayanan, and K. R. Mahadik, “Development of validated HPLC and HPTLC methods for simultaneous determination of levocetirizine dihydrochloride and montelukast sodium in bulk drug and pharmaceutical dosage form,” Pharmaceutica Analytica Acta, vol. 1, no. 1, pp. 1–6, 2010. View at Google Scholar
  27. T. Radhakrishnaa, A. Narasarajua, M. Ramakrishnab, and A. Satyanarayana, “Simultaneous determination of montelukast and loratadine by HPLC and derivative spectrophotometric methods,” Journal of Pharmaceutical and Biomedical Analysis, vol. 31, no. 2, pp. 359–368, 2003. View at Google Scholar
  28. R. T. Sane, A. Menezes, M. Mote, A. Moghe, and G. Gundi, “HPTLC determination of montelukast sodium in bulk drug and in pharmaceutical preparations,” Journal of Planar Chromatography - Modern TLC, vol. 17, no. 1, pp. 75–78, 2004. View at Publisher · View at Google Scholar · View at Scopus
  29. S. Al-Rawithi, S. Al-Gazlan, W. Al-Ahmadi, I. A. Alshowaier, A. Yusuf, and D. A. Raines, “Expedient liquid chromatographic method with fluorescence detection for montelukast sodium in micro-samples of plasma,” Journal of Chromatography B, vol. 754, no. 2, pp. 527–531, 2001. View at Publisher · View at Google Scholar · View at Scopus
  30. H. Ochiai, N. Uchiyama, T. Takano, K. I. Hara, and T. Kamei, “Determination of montelukast sodium in human plasma by column-switching high-performance liquid chromatography with fluorescence detection,” Journal of Chromatography B: Biomedical Applications, vol. 713, no. 2, pp. 409–414, 1998. View at Publisher · View at Google Scholar · View at Scopus
  31. B. Chauhan, S. Rani, M. Nivsarkar, and H. Padh, “A new liquid-liquid extraction method for determination of montelukast in small volume human plasma samples using HPLC with fluorescence detector,” Indian Journal of Pharmaceutical Sciences, vol. 68, no. 4, pp. 517–520, 2006. View at Google Scholar · View at Scopus
  32. L. Liu, H. Cheng, J. J. Zhao, and J. D. Rogers, “Determination of montelukast (MK-0476) and its S-enantiomer in human plasma by stereoselective high-performance liquid chromatography with column-switching,” Journal of Pharmaceutical and Biomedical Analysis, vol. 15, no. 5, pp. 631–638, 1997. View at Publisher · View at Google Scholar · View at Scopus
  33. R. Papp, P. Luk, W. M. Mullett, and E. Kwong, “A rapid and sensitive method for the quantitation of montelukast in sheep plasma using liquid chromatography/tandem mass spectrometry,” Journal of Chromatography B, vol. 858, no. 1-2, pp. 282–286, 2007. View at Publisher · View at Google Scholar · View at Scopus
  34. D. V. Bharathi, K. K. Hotha, B. Jagadeesh, R. Mullangi, and A. Naidu, “Quantification of montelukast, a selective cysteinyl leukotriene receptor (CysLT1) antagonist in human plasma by liquid chromatography-mass spectrometry: Validation and its application to a human pharmacokinetic study,” Biomedical Chromatography, vol. 23, no. 8, pp. 804–810, 2009. View at Publisher · View at Google Scholar · View at Scopus
  35. I. A. Alsarra, “Development of a stability-indicating HPLC method for the determination of montelukast in tablets and human plasma and its applications to pharmacokinetic and stability studies,” Saudi Pharmaceutical Journal, vol. 12, no. 4, pp. 136–143, 2004. View at Google Scholar · View at Scopus
  36. A. B. Eldin, A. A. Shalaby, and M. El-Tohamy, “Development and validation of a HPLC method for the determination of montelukast and its degradation products in pharmaceutical formulation using an experimental design,” Acta Pharmaceutica Sciencia, vol. 53, no. 1, pp. 45–56, 2011. View at Google Scholar · View at Scopus
  37. International Conference on Harmonization (ICH Q2 (R1). Validation of Analytical Procedures: Text and Methodology, IFPMA, Geneva, Switzerland, 2005.