Table of Contents
Chromatography Research International
Volume 2011 (2011), Article ID 214793, 11 pages
http://dx.doi.org/10.4061/2011/214793
Research Article

A Validated High-Performance Liquid Chromatography-Tandem Mass Spectrometric (Lc-Ms/Ms) Method for Simultaneous Determination of R(+)-Ketorolac and S(−)-Ketorolac in Human Plasma and Its Application to a Bioequivalence Study

Department of Clinical Pharmacology and Pharmacokinetics, Ranbaxy Research Laboratories, Plot: GP-5, Sec-18, HSIIDC, Old Delhi-Gurgaon Road, Gurgaon, Haryana 122 015, India

Received 23 July 2010; Revised 24 September 2010; Accepted 13 October 2010

Academic Editor: Wenkui Li

Copyright © 2011 Sabyasachi Patri 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. E. Mroszczak, D. Combs, and D. Combs, “Chiral kinetics and dynamics of ketorolac,” Journal of Clinical Pharmacology, vol. 36, no. 6, pp. 521–539, 1996. View at Google Scholar · View at Scopus
  2. R. E. Kauffman, M. W. Lieh-Lai, H. G. Uy, and M. K. Aravind, “Enantiomer-selective pharmacokinetics and metabolism of ketorolac in children,” Clinical Pharmacology and Therapeutics, vol. 65, no. 4, pp. 382–388, 1999. View at Google Scholar · View at Scopus
  3. W. H. Rooks II, A. J. Tomolonis, P. J. Maloney, M. B. Wallach, and M. E. Schuler, “The analgesic and anti-inflammatory profile of (±)-5-benzoyl-1,2dihydro-3H pyrrolo[1,2a]pyrrole-1-carboxylic acid (RS-37619),” Agents and Actions, vol. 12, no. 5-6, pp. 684–690, 1982. View at Google Scholar · View at Scopus
  4. K. R. Ing-Lorenzini, J. A. Desmeules, M. Besson, J.-L. Veuthey, P. Dayer, and Y. Daali, “Two-dimensional liquid chromatography-ion trap mass spectrometry for the simultaneous determination of ketorolac enantiomers and paracetamol in human plasma. Application to a pharmacokinetic study,” Journal of Chromatography A, vol. 1216, no. 18, pp. 3851–3856, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  5. A. T. Wu and I. J. Massey, “Simultaneous determination of ketorolac and its hydroxylated metabolite in plasma by high-performance liquid chromatography,” Journal of Chromatography, vol. 534, pp. 241–246, 1990. View at Publisher · View at Google Scholar · View at Scopus
  6. R. S. Chaudhary, S. S. Gangwal, K. C. Jindal, and S. Khanna, “Reversed-phase high-performance liquid chromatography of ketorolac and its application to bioequivalent studies in human serum,” Journal of Chromatography B, vol. 614, no. 1, pp. 180–184, 1993. View at Publisher · View at Google Scholar · View at Scopus
  7. D. Jung, E. J. Mroszczak, A. Wu, T. L. Ling, H. Sevelius, and L. Bynum, “Pharmacokinetics of ketorolac and p-hydroxyketorolac following oral and intramuscular administration of ketorolac tromethamine,” Pharmaceutical Research, vol. 6, no. 1, pp. 62–65, 1989. View at Google Scholar · View at Scopus
  8. M. Vakily, B. Corrigan, and F. Jamali, “The problem of racemization in the stereospecific assay and pharmacokinetic evaluation of ketorolac in human and rats,” Pharmaceutical Research, vol. 12, no. 11, pp. 1652–1657, 1995. View at Publisher · View at Google Scholar
  9. F. Jamali, F. M. Pasutto, and C. Lemko, “HPLC of ketorolac enantiomers and application to pharmacokinetics in the rat,” Journal of Liquid Chromatography, vol. 12, no. 10, pp. 1835–1850, 1989. View at Google Scholar · View at Scopus
  10. P. J. Hayball, J. G. Tamblyn, Y. Holden, and J. Wrobel, “Stereoselective analysis of ketorolac in human plasma by high-performance liquid chromatography,” Chirality, vol. 5, no. 1, pp. 31–35, 1993. View at Google Scholar · View at Scopus
  11. M. H. Mills, L. E. Mather, X. S. Gu, and J. L. Huang, “Determination of ketorolac enantiomers in plasma using enantioselective liquid chromatography on an α1-acid glycoprotein chiral stationary phase and ultraviolet detection,” Journal of Chromatography B, vol. 658, no. 1, pp. 177–182, 1994. View at Publisher · View at Google Scholar · View at Scopus
  12. D. J. Jones and A. R. Bjorksten, “Detection of ketorolac enantiomers in human plasma using enantioselective liquid chromatography,” Journal of Chromatography B, vol. 661, no. 1, pp. 165–167, 1994. View at Publisher · View at Google Scholar · View at Scopus
  13. M. J. Diaz-Perez, J. C. Chen, A.-F. Aubry, and I. W. Wainer, “The direct determination of the enantiomers of ketorolac and parahydroxyketorolac in plasma and urine using enantioselective liquid chromatography on a human serum albumin-based chiral stationary phase,” Chirality, vol. 6, no. 4, pp. 283–289, 1994. View at Publisher · View at Google Scholar · View at Scopus
  14. I. Tsina, Y. L. Tam, A. Boyd, C. Rocha, I. Massey, and T. Tarnowski, “An indirect (derivatization) and a direct HPLC method for the determination of the enantiomers of ketorolac in plasma,” Journal of Pharmaceutical and Biomedical Analysis, vol. 15, no. 3, pp. 403–417, 1996. View at Publisher · View at Google Scholar · View at Scopus
  15. M. A. Campanero, A. Löpez-Ocariz, E. García-Quetglas, B. Sâdaba, and J. R. Azanza, “Determination of ketorolac enantiomers in plasma using enantioselective liquid chromatography. Application to pharmacokinetic studies,” Chromatographia, vol. 48, no. 3-4, pp. 203–208, 1998. View at Google Scholar · View at Scopus
  16. “FDA Guidance for Industry: Bioanalytical Method Validation,,” 2001, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf.
  17. C. T. Viswanathan, S. Bansal, and S. Bansal, “Workshop/conference report—quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays,” AAPS Journal, vol. 9, no. 1, pp. E30–E42, 2007. View at Publisher · View at Google Scholar · View at Scopus