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Journal of Analytical Methods in Chemistry
Volume 2015 (2015), Article ID 892470, 12 pages
http://dx.doi.org/10.1155/2015/892470
Research Article

Development and Validation of an HPLC Method for Simultaneous Quantification of Clopidogrel Bisulfate, Its Carboxylic Acid Metabolite, and Atorvastatin in Human Plasma: Application to a Pharmacokinetic Study

1Faculty of Pharmacy, Department I of Pharmacy, University of Medicine and Pharmacy, Petru Rares Street, 200349 Craiova, Romania
2Faculty of Pharmacy, Doctoral School, University of Medicine and Pharmacy, Petru Rares Street, 200349 Craiova, Romania
3Faculty of Pharmacy, Department II of Pharmacy, University of Medicine and Pharmacy, Petru Rares Street, 200349 Craiova, Romania

Received 19 September 2015; Revised 23 November 2015; Accepted 30 November 2015

Academic Editor: Bengi Uslu

Copyright © 2015 Octavian Croitoru 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. C. W. Hamm, J.-P. Bassand, S. Agewall et al., “ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation,” European Heart Journal, vol. 32, no. 23, pp. 2999–3054, 2011. View at Publisher · View at Google Scholar · View at Scopus
  2. E. A. Amsterdam, N. K. Wenger, R. G. Brindis et al., “2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes,” Circulation, vol. 130, pp. e344–e426, 2014. View at Publisher · View at Google Scholar
  3. J.-M. Pereillo, M. Maftouh, A. Andrieu et al., “Structure and stereochemistry of the active metabolite of clopidogrel,” Drug Metabolism and Disposition, vol. 30, no. 11, pp. 1288–1295, 2002. View at Publisher · View at Google Scholar · View at Scopus
  4. M. Kazui, Y. Nishiya, T. Ishizuka et al., “Identification of the human cytochrome P450 enzymes involved in the two oxidative steps in the bioactivation of clopidogrel to its pharmacologically active metabolite,” Drug Metabolism and Disposition, vol. 38, no. 1, pp. 92–99, 2010. View at Publisher · View at Google Scholar · View at Scopus
  5. H. J. Bouman, E. Schömig, J. W. van Werkum et al., “Paraoxonase-1 is a major determinant of clopidogrel efficacy,” Nature Medicine, vol. 17, no. 1, pp. 110–116, 2011. View at Publisher · View at Google Scholar
  6. M. Igel, T. Sudhop, and K. Bergmann, “Pharmacology of 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins), including rosuvastatin and pitavastatin,” The Journal of Clinical Pharmacology, vol. 42, no. 8, pp. 835–845, 2002. View at Publisher · View at Google Scholar
  7. H. S. Malhotra and K. L. Goa, “Atorvastatin: an updated review of its pharmacological properties and use in dyslipidaemia,” Drugs, vol. 61, no. 12, pp. 1835–1881, 2001. View at Publisher · View at Google Scholar · View at Scopus
  8. A. P. Lea and D. McTavish, “Atorvastatin. A review of its pharmacology and therapeutic potential in the management of hyperlipidaemias,” Drugs, vol. 53, no. 5, pp. 828–847, 1997. View at Publisher · View at Google Scholar · View at Scopus
  9. M.-R. Rouini, Y. H. Ardakani, A. Foroumadi, H. Lavasani, and L. Hakemi, “Sensitive quantification of carboxylic acid metabolite of clopidogrel in human plasma by LC with UV detection,” Chromatographia, vol. 70, no. 5-6, pp. 953–956, 2009. View at Publisher · View at Google Scholar · View at Scopus
  10. G. Bahrami, B. Mohammadi, and S. Sisakhtnezhad, “High-performance liquid chromatographic determination of inactive carboxylic acid metabolite of clopidogrel in human serum: application to a bioequivalence study,” Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, vol. 864, no. 1-2, pp. 168–172, 2008. View at Publisher · View at Google Scholar · View at Scopus
  11. S. S. Singh, K. Sharma, D. Barot, P. R. Mohan, and V. B. Lohray, “Estimation of carboxylic acid metabolite of clopidogrel in Wistar rat plasma by HPLC and its application to a pharmacokinetic study,” Journal of Chromatography B, vol. 821, no. 2, pp. 173–180, 2005. View at Publisher · View at Google Scholar · View at Scopus
  12. H. Ksycinska, P. Rudzki, and M. Bukowska-Kiliszek, “Determination of clopidogrel metabolite (SR26334) in human plasma by LC–MS,” Journal of Pharmaceutical and Biomedical Analysis, vol. 41, no. 2, pp. 533–539, 2006. View at Publisher · View at Google Scholar · View at Scopus
  13. A. Mitakos and I. Panderi, “Determination of the carboxylic acid metabolite of clopidogrel in human plasma by liquid chromatography-electrospray ionization mass spectrometry,” Analytica Chimica Acta, vol. 505, no. 1, pp. 107–114, 2004. View at Publisher · View at Google Scholar · View at Scopus
  14. M. Karaźniewicz-Łada, D. Danielak, A. Tezyk, C. zaba, G. Tuffal, and F. Główka, “HPLC-MS/MS method for the simultaneous determination of clopidogrel, its carboxylic acid metabolite and derivatized isomers of thiol metabolite in clinical samples,” Journal of Chromatography B, vol. 911, pp. 105–112, 2012. View at Publisher · View at Google Scholar · View at Scopus
  15. L. Silvestro, M. C. Gheorghe, I. Tarcomnicu et al., “Development and validation of an HPLC-MS/MS method to determine clopidogrel in human plasma. Use of incurred samples to test back-conversion,” Journal of Chromatography B, vol. 878, no. 30, pp. 3134–3142, 2010. View at Publisher · View at Google Scholar · View at Scopus
  16. R. Reddy S, K. Rao.Divi, I. S. chandiran, K. N. Jayaveera, Y. K. Naidu, and M. P. K. Reddy, “Development and validation of high-throughput liquid chromatography-tandem mass spectrometric method for simultaneous quantification of Clopidogrel and its metabolite in human plasma,” Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, vol. 878, no. 3-4, pp. 502–508, 2010. View at Publisher · View at Google Scholar · View at Scopus
  17. G. Di Girolamo, P. Czerniuk, R. Bertuola, and G. A. Keller, “Bioequivalence of two tablet formulations of clopidogrel in healthy Argentinian volunteers: a single-dose, randomized-sequence, open-label crossover study,” Clinical Therapeutics, vol. 32, no. 1, pp. 161–170, 2010. View at Publisher · View at Google Scholar · View at Scopus
  18. D. S. Small, C. D. Payne, P. Kothare et al., “Pharmacodynamics and pharmacokinetics of single doses of prasugrel 30 mg and clopidogrel 300 mg in healthy Chinese and white volunteers: an open-label trial,” Clinical Therapeutics, vol. 32, no. 2, pp. 365–379, 2010. View at Publisher · View at Google Scholar · View at Scopus
  19. J.-J. Zou, H.-W. Fan, D.-Q. Guo et al., “Simultaneous determination of clopidogrel and its carboxylic acid metabolite (SR26334) in human plasma by LC-ESI-MS-MS: application to the therapeutic drug monitoring of clopidogrel,” Chromatographia, vol. 70, no. 11-12, pp. 1581–1586, 2009. View at Publisher · View at Google Scholar
  20. A. Robinson, J. Hillis, C. Neal, and A. C. Leary, “The validation of a bioanalytical method for the determination of clopidogrel in human plasma,” Journal of Chromatography B, vol. 848, no. 2, pp. 344–354, 2007. View at Publisher · View at Google Scholar · View at Scopus
  21. M. T. Furlong, I. Savant, M. Yuan et al., “A validated HPLC-MS/MS assay for quantifying unstable pharmacologically active metabolites of clopidogrel in human plasma: application to a clinical pharmacokinetic study,” Journal of Chromatography B, vol. 926, pp. 36–41, 2013. View at Publisher · View at Google Scholar · View at Scopus
  22. C. J. Peer, S. D. Spencer, D. A. H. VanDenBerg, M. A. Pacanowski, R. B. Horenstein, and W. D. Figg, “A sensitive and rapid ultra HPLC-MS/MS method for the simultaneous detection of clopidogrel and its derivatized active thiol metabolite in human plasma,” Journal of Chromatography B, vol. 880, no. 1, pp. 132–139, 2012. View at Publisher · View at Google Scholar · View at Scopus
  23. G. Tuffal, S. Roy, M. Lavisse et al., “An improved method for specific and quantitative determination of the clopidogrel active metabolite isomers in human plasma,” Thrombosis and Haemostasis, vol. 105, no. 4, pp. 696–705, 2011. View at Publisher · View at Google Scholar · View at Scopus
  24. M. Takahashi, H. Pang, K. Kawabata, N. A. Farid, and A. Kurihara, “Quantitative determination of clopidogrel active metabolite in human plasma by LC–MS/MS,” Journal of Pharmaceutical and Biomedical Analysis, vol. 48, no. 4, pp. 1219–1224, 2008. View at Publisher · View at Google Scholar · View at Scopus
  25. G. Bahrami, B. Mohammadi, S. Mirzaeei, and A. Kiani, “Determination of atorvastatin in human serum by reversed-phase high-performance liquid chromatography with UV detection,” Journal of Chromatography B, vol. 826, no. 1-2, pp. 41–45, 2005. View at Publisher · View at Google Scholar · View at Scopus
  26. J. Hassan and S. H. Bahrani, “Determination of atorvastatin in human serum by salting out assisted solvent extraction and reversed-phase high-performance liquid chromatography-UV detection,” Arabian Journal of Chemistry, vol. 7, no. 1, pp. 87–90, 2014. View at Publisher · View at Google Scholar · View at Scopus
  27. P. Partani, S. M. Verma, S. Gurule, A. Khuroo, and T. Monif, “Simultaneous quantitation of atorvastatin and its two active metabolites in human plasma by liquid chromatography/(–) electrospray tandem mass spectrometry,” Journal of Pharmaceutical Analysis, vol. 4, no. 1, pp. 26–36, 2014. View at Publisher · View at Google Scholar · View at Scopus
  28. M. Hermann, H. Christensen, and J. L. E. Reubsaet, “Determination of atorvastatin and metabolites in human plasma with solid-phase extraction followed by LC–tandem MS,” Analytical and Bioanalytical Chemistry, vol. 382, no. 5, pp. 1242–1249, 2005. View at Publisher · View at Google Scholar · View at Scopus
  29. L. Ma, J. Dong, X. J. Chen, and G. J. Wang, “Development and validation of atorvastatin by LC-ESI-MS and application in bioequivalence research in healthy Chinese volunteers,” Chromatographia, vol. 65, no. 11-12, pp. 737–741, 2007. View at Publisher · View at Google Scholar · View at Scopus
  30. Y. Zhou, J. Li, X. He et al., “Development and validation of a liquid chromatography-tandem mass spectrometry method for simultaneous determination of amlodipine, atorvastatin and its metabolites ortho-hydroxy atorvastatin and para-hydroxy atorvastatin in human plasma and its application in a bioequivalence study,” Journal of Pharmaceutical and Biomedical Analysis, vol. 83, pp. 101–107, 2013. View at Publisher · View at Google Scholar · View at Scopus
  31. M. Yacoub, A. Abu Awwad, M. Alawi, and T. Arafat, “Simultaneous determination of amlodipine and atorvastatin with its metabolites; ortho and para hydroxy atorvastatin; in human plasma by LC–MS/MS,” Journal of Chromatography B, vol. 917-918, pp. 36–47, 2013. View at Publisher · View at Google Scholar
  32. S. R. Polagani, N. R. Pilli, R. Gajula, and V. Gandu, “Simultaneous determination of atorvastatin, metformin and glimepiride in human plasma by LC–MS/MS and its application to a human pharmacokinetic study,” Journal of Pharmaceutical Analysis, vol. 3, no. 1, pp. 9–19, 2013. View at Publisher · View at Google Scholar
  33. Y. Shah, Z. Iqbal, L. Ahmad et al., “Simultaneous determination of rosuvastatin and atorvastatin in human serum using RP-HPLC/UV detection: method development, validation and optimization of various experimental parameters,” Journal of Chromatography B, vol. 879, no. 9-10, pp. 557–563, 2011. View at Publisher · View at Google Scholar · View at Scopus
  34. L. Nováková, H. Vlčková, D. Šatínský et al., “Ultra high performance liquid chromatography tandem mass spectrometric detection in clinical analysis of simvastatin and atorvastatin,” Journal of Chromatography B, vol. 877, no. 22, pp. 2093–2103, 2009. View at Publisher · View at Google Scholar
  35. ICH, “Validation of analytical procedures and methodology,” in Proceedings of the International Conference on Harmonization, Geneva, Switzerland, 2005.
  36. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice E6(R10) Current Step 4 Version, 1996.
  37. M. A. Hedaya, “Extravascular routes of drug administration,” in Basic Pharmacokinetics, chapter 6, pp. 105–126, 2nd edition, 2012. View at Google Scholar