Table of Contents
Chromatography Research International
Volume 2013 (2013), Article ID 963595, 9 pages
http://dx.doi.org/10.1155/2013/963595
Research Article

A Validated New Gradient Stability-Indicating LC Method for the Analysis of Doripenem in Bulk and Injection Formulation

1Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi Road, Guntur 522 002, India
2Department of Pharmaceutical Analysis, K.V.S.R Siddhartha College of Pharmaceutical Sciences, Vijayawada 520 101, India

Received 12 February 2013; Revised 18 March 2013; Accepted 19 March 2013

Academic Editor: Antonio Martín-Esteban

Copyright © 2013 Singaram Kathirvel and Garikapati Devalarao. 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. R. N. Jones, H. S. Sader, and T. R. Fritsche, “Comparative activity of doripenem and three other carbapenems tested against Gram-negative bacilli with various β-lactamase resistance mechanisms,” Diagnostic Microbiology and Infectious Disease, vol. 52, no. 1, pp. 71–74, 2005. View at Publisher · View at Google Scholar · View at Scopus
  2. H. M. Wexler, A. E. Engel, D. Glass, and C. Li, “In vitro activities of doripenem and comparator agents against 364 anaerobic clinical isolates,” Antimicrobial Agents and Chemotherapy, vol. 49, no. 10, pp. 4413–4417, 2005. View at Publisher · View at Google Scholar · View at Scopus
  3. R. N. Jones, H. K. Huynh, and D. J. Biedenbach, “Activities of doripenem (S-4661) against drug-resistant clinical pathogens,” Antimicrobial Agents and Chemotherapy, vol. 48, no. 8, pp. 3136–3140, 2004. View at Publisher · View at Google Scholar · View at Scopus
  4. P. A. Psathas, A. Kuzmission, K. Ikeda, and S. Yasuo, “Stability of doripenem in vitro in representative infusion solutions and infusion bags,” Clinical Therapeutics, vol. 30, no. 11, pp. 2075–2087, 2008. View at Publisher · View at Google Scholar · View at Scopus
  5. C. Sutherland and D. P. Nicolau, “Development of an HPLC method for the determination of doripenem in human and mouse serum,” Journal of Chromatography B, vol. 853, no. 1-2, pp. 123–126, 2007. View at Publisher · View at Google Scholar · View at Scopus
  6. J. Cielecka-Piontek, A. Jelińska, A. Dołhań, and P. Zalewski, “Kinetic and thermodynamic analysis of degradation of doripenem in the solid state,” International Journal of Chemical Kinetics, vol. 44, pp. 722–728, 2012. View at Publisher · View at Google Scholar
  7. L. Mantovani, C. T. M. Sayago, V. B. Camargo et al., “Stability-indicating RP-HPLC method for analysis of the antibiotic doripenem in pharmaceutical formulation-comparison to UV spectrophotometry and microbiological assay,” Acta Chromatographica, vol. 24, pp. 367–382, 2012. View at Publisher · View at Google Scholar
  8. J. Cielecka-Piontek and A. Jelinska, “The UV-Derivative spectrophotometry for the determination of doripenem in the presence of its degradation products,” Spectrochimica Acta A, vol. 77, pp. 554–557, 2010. View at Publisher · View at Google Scholar
  9. J. Cielecka-Piontek, K. Michalska, P. Zalewski, and A. Jelińska, “Recent advances in stability studies of carbapenems,” Current Pharmaceutical Analysis, vol. 7, pp. 213–227, 2011. View at Publisher · View at Google Scholar
  10. E. Dailly, R. Bouquié, G. Deslandes, P. Jolliet, and R. le Floch, “A liquid chromatography assay for a quantification of doripenem, ertapenem, imipenem, meropenem concentrations in human plasma: application to a clinical pharmacokinetic study,” Journal of Chromatography B, vol. 879, no. 15-16, pp. 1137–1142, 2011. View at Publisher · View at Google Scholar · View at Scopus
  11. K. Michalska, G. Pajchel, and S. Tyski, “Determination of doripenem and related substances in medicinal product using capillary electrophoresis,” Journal of Separation Science, vol. 34, no. 4, pp. 475–482, 2011. View at Publisher · View at Google Scholar · View at Scopus
  12. J. L. Crandon, C. Sutherland, and D. P. Nicolau, “Stability of doripenem in polyvinyl chloride bags and elastomeric pumps,” American Journal of Health-System Pharmacy, vol. 67, no. 18, pp. 1539–1544, 2010. View at Publisher · View at Google Scholar · View at Scopus
  13. K. Berthoin, C. S. le Duff, J. Marchand-Brynaert, S. Carryn, and P. M. Tulkens, “Stability of meropenem and doripenem solutions for administration by continuous infusion,” Journal of Antimicrobial Chemotherapy, vol. 65, no. 5, pp. 1073–1075, 2010. View at Publisher · View at Google Scholar · View at Scopus
  14. ICH Q1A (R2), “Stability Testing of New Drug Substances and Products,” 2003.
  15. ICH Q2 (R1), “Validation of Analytical Procedures: Text and Methodology,” 2005.
  16. “Stability testing of new drug substance and products Q1A (R2),” in Proceedings of the International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, pp. 1–18, February 2003.