Chromatography Research International
Volume 2012 (2012), Article ID 801720, 13 pages
http://dx.doi.org/10.1155/2012/801720
Research Article

Development and Validation of a Stability Indicating LC Method for the Assay and Related Substances Determination of a Proteasome Inhibitor Bortezomib

1Active Pharmaceutical Ingredients, Dr. Reddy's Laboratories Ltd., IPDO, Bachupally, Hyderabad 500072, Andhra Pradesh, India
2Department of Chemistry, Osmania University, Hyderabad 500072, Andhra Pradesh, India
3Matrix Laboratories Limited, Plot 34 A, Anrich Industrial Estate, Bollaram, Medak District, Jinnaram, Mandal 502 32, Andhra Pradesh, India

Received 24 February 2012; Accepted 10 May 2012

Academic Editor: Esther Turiel

Copyright © 2012 Kasa Srinivasulu 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. J. Adams and R. Stein, “Novel Inhibitors of the Proteasome and Their Therapeutic Use in Inflammation,” Annual Reports in Medicinal Chemistry, vol. 31, no. C, pp. 279–288, 1996. View at Publisher · View at Google Scholar · View at Scopus
  2. J. Adams, “The proteasome: a suitable antineoplastic target,” Nature Reviews Cancer, vol. 4, no. 5, pp. 349–360, 2004. View at Google Scholar · View at Scopus
  3. J. Adams, Y. Ma, R. Stein, M. Baevsky, L. Grenier, and L. Plamondon, “Boronic ester and acid compounds, synthesis and uses,” 1996, US, 1448.012TW01.
  4. P. G. Richardson, T. Hideshima, and K. C. Anderson, “Bortezomib (PS-341): a novel, first-in-class proteasome inhibitor for the treatment of multiple myeloma and other cancers,” Cancer Control, vol. 10, no. 5, pp. 361–369, 2003. View at Google Scholar · View at Scopus
  5. R. J. Snow and W. W. Bachovchin, “Boronic acid inhibitors of dipeptidyl peptidase IV. A new class of immunosuppressive agents,” Advances in Medicinal Chemistry, vol. 3, no. C, pp. 149–177, 1995. View at Publisher · View at Google Scholar · View at Scopus
  6. European Medicines Agency, “European public assessment report: scientific discussion. The committee for medicinal products for human use,” 2004, http://www.emea.eu.int/humandocs/Humans/EPAR/velcade/velcade.htm.
  7. J. S. Daniels, T. Pekol, J. Labutti et al., “Human metabolism of the proteasome inhibitor bortezomib: identification of circulating metabolites,” Drug Metabolism and Disposition, vol. 33, no. 6, pp. 771–777, 2005. View at Publisher · View at Google Scholar · View at Scopus
  8. P. André, S. Cisternino, F. Chiadmi et al., “Stability of bortezomib 1-mg/mL solution in plastic syringe and glass vial,” Annals of Pharmacotherapy, vol. 39, no. 9, pp. 1462–1466, 2005. View at Publisher · View at Google Scholar · View at Scopus
  9. D. D. Jandial, S. Farshchi-Heydari, C. A. Larson, G. I. Elliott, W. J. Wrasidlo, and S. B. Howell, “Enhanced delivery of cisplatin to intraperitoneal ovarian carcinomas mediated by the effects of bortezomib on the human copper transporter 1,” Clinical Cancer Research, vol. 15, no. 2, pp. 553–560, 2009. View at Publisher · View at Google Scholar · View at Scopus
  10. J. S. Johnston, M. A. Phelps, K. A. Blum et al., “Development and validation of a rapid and sensitive high-performance liquid chromatography-mass spectroscopy assay for determination of 17-(allylamino)-17-demethoxygeldanamycin and 17-(amino)-17-demethoxygeldanamycin in human plasma,” Journal of Chromatography B, vol. 871, no. 1, pp. 15–21, 2008. View at Publisher · View at Google Scholar · View at Scopus
  11. ICH Q1A(R2), “Stability Testing of New Drug Substances and Products,” 2000. View at Google Scholar
  12. I. C. H. Stability, “Testing of New Drug Substances and Products Q1A (R2),” in Proceedings of the International Conference on Harmonization (IFPMA '03), Geneva, Switzerland, 2003.
  13. United States pharmacopoeia, United States Pharmacopeial Convention, Rockville, Md, USA, 31st edition, 2008.
  14. T. C. Jens and C. T. Rhodes, Drug Stability Principles and Practices, 3rd, Marcel Dekker, New York, NY, USA.
  15. M. Bakshi and S. Singh, “Development of validated stability-indicating assay methods—critical review,” Journal of Pharmaceutical and Biomedical Analysis, vol. 28, no. 6, pp. 1011–1040, 2002. View at Publisher · View at Google Scholar · View at Scopus
  16. ICH Q2 (R1), “Validation of Analytical Procedures: Text and Methodology,” 2005. View at Google Scholar
  17. G. A. Shabir, “Validation of high-performance liquid chromatography methods for pharmaceutical analysis: understanding the differences and similarities between validation requirements of the US Food and Drug Administration, the US Pharmacopeia and the International Conference on Harmonization,” Journal of Chromatography A, vol. 987, no. 1-2, pp. 57–66, 2003. View at Publisher · View at Google Scholar
  18. M. Ribani, C. B. Grespan Bottoli, C. H. Collins, I. C. S. Fontes Jardim, and L. F. Costa Melo, “Validation for chromatographic and electrophoretic methods,” Quimica Nova, vol. 27, no. 5, pp. 771–780, 2004. View at Google Scholar · View at Scopus
  19. Y. Vander Heyden, A. Nijhuis, J. Smeyers-Verbeke, B. G. M. Vandeginste, and D. L. Massart, “Guidance for robustness/ruggedness tests in method validation,” Journal of Pharmaceutical and Biomedical Analysis, vol. 24, no. 5-6, pp. 723–753, 2001. View at Publisher · View at Google Scholar · View at Scopus
  20. D. K. Lin, “Discussion on papers by Box and Liu, Box, and Myers,” Journal of Quality Technology, vol. 31, pp. 61–66, 1999. View at Google Scholar
  21. K. K. Hockman and D. Berengut, “Design of experiments,” Chemical Engineering, vol. 102, pp. 142–148, 1995. View at Google Scholar
  22. H. Fabre, “Robustness testing in liquid chromatography and capillary electrophoresis,” Journal of Pharmaceutical and Biomedical Analysis, vol. 14, pp. 1125–1132, 1996. View at Google Scholar
  23. B. Singh, R. Kumar, and N. Ahuja, “Optimizing drug delivery systems using systematic “design of experiments.” Part I: fundamental aspects,” Critical Reviews in Therapeutic Drug Carrier Systems, vol. 22, pp. 27–105, 2004. View at Google Scholar
  24. S. Pinzauti, P. Gratteri, S. Furlanetto, P. Mura, E. Dreassi, and R. Phan-Tan-Luu, “Experimental design in the development of voltammetric method for the assay of omeprazole,” Journal of Pharmaceutical and Biomedical Analysis, vol. 14, no. 8-10, pp. 881–889, 1996. View at Publisher · View at Google Scholar · View at Scopus
  25. S. Wu, W. Waugh, and V. J. Stella, “Degradation pathways of a peptide boronic acid derivative, 2–Pyz–(CO)–Phe–Leu–B(OH)2,” Journal of Pharmaceutical Sciences, vol. 89, pp. 758–765, 2000. View at Google Scholar