Table of Contents
Chromatography Research International
Volume 2013 (2013), Article ID 676501, 9 pages
http://dx.doi.org/10.1155/2013/676501
Research Article

Implementation of QbD Approach to the Analytical Method Development and Validation for the Estimation of Propafenone Hydrochloride in Tablet Dosage Form

Pharmaceutical Chemistry Department, M.G.V’s Pharmacy College, Panchavati, Nashik 422003, India

Received 9 January 2013; Accepted 26 February 2013

Academic Editor: Irene Panderi

Copyright © 2013 Monika L. Jadhav and Santosh R. Tambe. 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. ICH Topic Q8 (R2), “ICH harmonised tripartite guideline,” in Proceedings of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH '09), Pharmaceutical Development, 2009.
  2. A. B. Godfrey and R. S. Kenett, “Joseph M. Juran, a perspective on past contributions and future impact,” Quality and Reliability Engineering International, vol. 23, no. 6, pp. 653–663, 2007. View at Google Scholar · View at Scopus
  3. P. Nethercote, P. Borman, T. Bennett et al., QbD for Better Method Validation & Transfer, Pharmaceutical Manufacturing, 2010.
  4. ICH Topic Q2 (R1), “ICH harmonised tripartite guideline,” in Proceedings of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH '94), Validation of Analytical Procedures, 1994.
  5. ICH Topic Q9, “ICH harmonised tripartite guideline,” in Proceedings of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH '94), Quality Risk Management, 2005.
  6. P. Borman, P. Nethercote, M. Chatfield et al., The Application of Quality by Design to Analytical Methods, PharmTech, 2007.
  7. L. X. Yu, “Pharmaceutical quality by design: product and process development, understanding, and control,” Pharmaceutical Research, vol. 25, no. 4, pp. 781–791, 2008. View at Publisher · View at Google Scholar · View at Scopus
  8. M. Pohl, M. Schweitzer, G. Hansen et al., “Implications and opportunities of applying the principles of QbD to analytical measurements,” Pharmaceutical Technology Europe, vol. 22, no. 2, pp. 29–36, 2010. View at Google Scholar · View at Scopus
  9. The United States Pharmacopoeia 27, the National Formulary 22, Asian Edition, United States Pharmacopoeial Convection, 2004.
  10. C. M. de Gaitani, V. L. Lanchote, and P. S. Bonato, “Enantioselective analysis of propafenone in plasma using a polysaccharide-based chiral stationary phase under reversed-phase conditions,” Journal of Chromatography B, vol. 708, no. 1-2, pp. 177–183, 1998. View at Publisher · View at Google Scholar · View at Scopus
  11. Y. Wu, M. Ma, and S. Zeng, “Enantioselective assay of S(+)- and R(-)-propafenone in human urine by using RP-HPLC with pre-column chiral derivatization,” Journals of Zhejiang University-Science A, vol. 5, no. 2, pp. 226–229, 2004. View at Google Scholar
  12. D. Zhong and X. Chen, “Enantioselective determination of propafenone and its metabolites in human plasma by liquid chromatography-mass spectrometry,” Journal of Chromatography B, vol. 721, no. 1, pp. 67–75, 1999. View at Publisher · View at Google Scholar · View at Scopus
  13. L. R. P. de Abreu, V. L. Lanchote, C. Bertucci, E. J. Cesarino, and P. S. Bonato, “Simultaneous determination of propafenone and 5-hydroxypropafenone enantiomers in plasma by chromatography on an amylose derived chiral stationary phase,” Journal of Pharmaceutical and Biomedical Analysis, vol. 20, no. 1-2, pp. 209–216, 1999. View at Publisher · View at Google Scholar · View at Scopus
  14. U. Hofmann, M. Pecia, G. Heinkele, K. Dilger, H. K. Kroemer, and M. Eichelbaum, “Determination of propafenone and its phase I and phase II metabolites in plasma and urine by high-performance liquid chromatography-electrospray ionization mass spectrometry,” Journal of Chromatography B, vol. 748, no. 1, pp. 113–123, 2000. View at Publisher · View at Google Scholar · View at Scopus
  15. M. Schweitzer, M. Pohl, M. Hanna-Brown et al., “Implications and opportunities of applying QbD principles to analytical measurements,” Pharmaceutical Technology, vol. 34, no. 2, pp. 52–59, 2010. View at Google Scholar
  16. R. M. Bianchini, P. M. Castellano, and T. S. Kaufman, “Development and validation of an HPLC method for the determination of process-related impurities in pridinol mesylate, employing experimental designs,” Analytica Chimica Acta, vol. 654, no. 2, pp. 141–147, 2009. View at Publisher · View at Google Scholar · View at Scopus
  17. K. Monks, I. Molnar, H. J. Rieger, B. Bogati, and E. Szabo, “Quality by design: multidimensional exploration of the design space in high performance liquid chromatography method development for better robustness before validation,” Journal of Chromatography A, vol. 1232, pp. 218–230, 2012. View at Google Scholar
  18. G. Srinubabu, C. A. I. Raju, N. Sarath, P. K. Kumar, and J. V. L. N. S. Rao, “Development and validation of a HPLC method for the determination of voriconazole in pharmaceutical formulation using an experimental design,” Talanta, vol. 71, no. 3, pp. 1424–1429, 2007. View at Publisher · View at Google Scholar · View at Scopus
  19. S. M. Khamanga and R. B. Walker, “The use of experimental design in the development of an HPLC-ECD method for the analysis of captopril,” Talanta, vol. 83, no. 3, pp. 1037–1049, 2011. View at Publisher · View at Google Scholar · View at Scopus
  20. E. M. Sheldon and J. B. Downar, “Development and validation of a single robust HPLC method for the characterization of a pharmaceutical starting material and impurities from three suppliers using three separate synthetic routes,” Journal of Pharmaceutical and Biomedical Analysis, vol. 23, no. 2-3, pp. 561–572, 2000. View at Publisher · View at Google Scholar · View at Scopus
  21. P. F. Gavin and B. A. Olsen, “A quality by design approach to impurity method development for atomoxetine hydrochloride (LY139603),” Journal of Pharmaceutical and Biomedical Analysis, vol. 46, no. 3, pp. 431–441, 2008. View at Publisher · View at Google Scholar · View at Scopus
  22. B. Dejaegher and Y. vander Heyden, “Experimental designs and their recent advances in set-up, data interpretation, and analytical applications,” Journal of Pharmaceutical and Biomedical Analysis, vol. 56, no. 2, pp. 141–158, 2011. View at Publisher · View at Google Scholar · View at Scopus
  23. D. Awotwe-Otooa, C. Agarabia, P. J. Faustinoa et al., “Application of quality by design elements for the development and optimization of an analytical method for protamine sulfate,” Journal of Pharmaceutical and Biomedical Analysis, vol. 62, pp. 61–67, 2012. View at Google Scholar
  24. B. Vasselle, G. Gousset, and J. P. Bounine, “Development and validation of a high-performance liquid chromatographic stability-indicating method for the analysis of Synercid in quality control, stability and compatibility studies,” Journal of Pharmaceutical and Biomedical Analysis, vol. 19, no. 5, pp. 641–657, 1999. View at Publisher · View at Google Scholar · View at Scopus