Determination of aliskiren in tablet dosage forms by a validated stability-indicating RP-LC method

Journal of Chromatographic Science

Volumn 49, Issue 2, 2011, Pages 170-175

  Wrasse Sangoi, M ^a   Sangoi, M S ^b   Oliveira, P R ^c   Secretti, L T ^a   Rolim, C M B ^a  

^a FEDERAL UNIVERSITY OF SANTA MARIA   (Brazil)

^b FEDERAL UNIVERSITY OF RIO GRANDE DO SUL   (Brazil)

^c FEDERAL UNIVERSITY OF SANTA CATARINA   (Brazil)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 78751554551     PISSN: 00219665     EISSN: None     Source Type: Journal    
DOI: 10.1093/chrsci/49.2.170     Document Type: Article

References (35)

1. A. C. Chobanian, G. L. Bakris, H. R. Black, W. C. Cushman, L. A. Green, J. L. Izzo, D. W. Jones, B. J. Materson, S. Oparil, J. K. Wright Jr., and E. J. Roccella. The seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure. The JNC 7 report. JAMA 289:2560-2572 (2003).
2. R. L. Antikainen, V. A. Moltchanov, C. Chukwuma, K. A. Kuulasmaa, P. M. Marques-Vidal, S. Sans, L. Wilhelmsen, and J. A. Tuomilehto. Trends in the prevalence, awareness, treatment and control of hypertension: The WHO MONICA project. Eur. J. Cardiovasc. Prev. Rehabil. 13:13-29 (2006).
3. K. K. Gaddam, A. Verma, M. Thompson, R. Amin, and H. Ventura. Hypertension and cardiac failure in its various forms. Med Clin. North Am. 93:665-680 (2009).
4. C. M. Tice, Z. Xu, J. Yuan, R. D. Simpson, S. T. Cacatian, P. T. Flaherty, W. Zhao, J. Guo, A. Ishchenko, S. B. Singh, Z. Wua, B. B. Scott, Y. Bukhtiyarov, J. Berbaum, J. Mason, R. Panemangalore, M. G. Cappiello, D. Müller, R. K. Harrison, G. M. McGeehan, L. W. Dillard, J. J. Baldwin, and D. A. Claremon. Design and optimization of renin inhibitors: Orally bioavailable alkyl amines. Bioorg. Med. Chem. Lett. 19:3541-3545 (2009).
5. M. A. Zaman, S. Oparil, and D. A. Calhoun. Drugs targeting the renin-angiotensinaldosterone system. Nat Rev. Drug Discov. 1:621-636 (2002).
6. B. B. Scott, G. McGeehan, and R. K. Harrison. Development of inhibitors of the aspartyl protease renin for the treatment of hypertension. Curr. Protein Pept. Sci. 7:241-254 (2006).
7. J. A. Staessen, Y. Li, and T. Richart. Oral renin inhibitors. Lancet 368:1449-1456 (2006).
8. P. Verdecchia, F. Angeli, G. Mazzotta, G. Gentile, and G. Reboldi. The renin angiotensin system in the development of cardiovascular disease: role of aliskiren in risk reduction. Vasc. Health RiskManag. 4(5):971-981 (2008).
9. J. Iwanami, M. Mogi, M. Iwai, and M. Horiuchi. Inhibition of the renin-angiotensin system and target organ protection. Hypertens. Res. 32:229-237 (2009).
10. J. Rahuel, V. Rasetti, J. Maibaum, H. Rüeger, R. Göschke, N.-C. Cohen, S. Stutz, F. Cumin, W. Fuhrer, J. M. Wood, and M. G. Grütter. Structure-based drug design: the discovery of novel nonpeptide orally active inhibitors of human renin. Chem. Biol. 7:493-504 (2000).
11. J. M. Wood, J. Maibaum, J. Rahuel, M. G. Grutter,; N. C. Cohen, V. Rasetti, H. Ruger, R. Goschke, S. Stutz, W. Fuhrer, W. Schilling, P. Rigollier, Y. Yamaguchi, F. Cumin, H.-P. Baum, C. R. Schnell, P. Herold, R. Mah, C. Jensen, E. O'Brien, A. Stanton, and M. P. Bedigian. Structure-based design of aliskiren, a novel orally effective renin inhibitor. Biochem. Biophys. Res. Commun. 308:698-705 (2003).'
12. H. Dong, Z.-L. Zhang, J.-H. Huang, R. Ma, S.-H. Chen, and G. Li. Practical synthesis of an orally active renin inhibitor aliskiren. Tetrahedron Lett. 46:6337-6340 (2005).
13. N. Andrushko, V. Andrushko, T. Thyrann, G. König, and A. Börner. Synthesis of enantiopure (r)-2-(4-methoxy-3-(3-methoxypropoxy)- benzyl)-3-methylbutanoic acid - a key intermediate for the preparation of aliskiren. Tetrahedron Lett. 49:5980-5982 (2008).
14. S. Vaidyanathan, D. Limoges, C.-M. Yeh, and H. A. Dieterich, Aliskiren, an orally effective renin inhibitor, shows dose linear pharmacokinetics in healthy volunteers. Clin. Pharmacol. Ther. 79:64 (PIII-23) (2006).
15. C. Jensen, P. Herold, and H. R. Brunner. Aliskiren: The first renin inhibitor for clinical treatment. Nat. Rev. Drug Discov. 7:399-410 (2008).
16. F. Waldmeier, U. Glaenzel, B. Wirz, L. Oberer, D. Schmid, M. Seiberling, J. Valencia, G.-J. Riviere, P. End, and S. Vaidyanathan. Absorption, distribution, metabolism, and elimination of the direct renin inhibitor aliskiren in healthy volunteers. DrugMetab. Dispos. 35:1418-1428 (2007).
17. W. Buczko and J. M. Hermanowicz. Pharmacokinetics and pharmacodynamics of aliskiren, an oral direct renin inhibitor. Pharmacol. Rep. 60:623-631 (2008).
18. G. Lefevre and S. Gauromb. Automated quantitative determination of the new renin inhibitor cgp 60536 by high-performance liquid chromatography. J. Chromatogr. B 738:129-136 (2000).
19. S. Vaidyanathan, V. Warren, C. Yeh, M.-N. Bizot, H. A. Dieterich, and W. P. Dole. Pharmacokinetics, safety, and tolerability of the oral renin inhibitor aliskiren in patients with hepatic impairment. J. Clin. Pharmacol. 47:192-200 (2007).
20. Chemical Tests and Assays. Titrimetric. In The United States Pharmacopoeia, 31th Ed. (USP31), United States Convention, Rockville, USA, 2008, pp. 185-187.
21. G. A. Shabir, W. J. Lough, S. A. Arain, and T. K. Bradshaw. Evaluation and application of best practice in analytical method validation. J. Liq. Chrom. Rel. Technol. 30:311-333 (2007).
22. International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceutical for Human Use. Validation of Analytical Procedures: Text and Methodology Q2 (R1), Geneva, 2005.
23. K. M. Alsante, A. Ando, R. Brown, J. Ensing, T. D. Hatajik, W. Kong, and Y. Tsuda. The role of degradant profiling in active pharmaceutical ingredients and drug products. Adv. Drug Deliv. Rev. 59:29-37 (2007).
24. M. Bakshi and S. Singh. Development of validated stability-indicating assay methods-critical review. J. Pharm. Biomed. Anal. 28:1011-1040 (2002).
25. J. R. Bhinge, R. V. Kumar, and V. R. Sinha. A simple and sensitive stability-indicating RP-HPLC assay method for the determi nation of aceclofenac. J. Chromatogr. Sci. 46:440-444 (2008).
26. R. N. Rao and A. N. Raju. Development and validation of a reversed-phase HPLC method for separation and simultaneous determinations of process-related substances of mirtazapine in bulk drugs and formulations. J. Chromatogr. Sci. 47:223-230 (2009).
27. R. C. Rowe, P. J. Sheskey, and S. C. Owen. Handbook of Pharmaceutical Excipients, 5th ed. Pharmaceutical Press, Grayslake, 2006.
28. R. Thompson and R. LoBrutto. "Role of HPLC in Progress Development". In HPLC for Pharmaceutical Scientists. Y. Kazakevich and R. LoBrutto, Eds. John Wiley & Sons, New Jersey, 2007, pp. 641-677.
29. Z. Li. High throughput analysis in support of process chemistry and formulation research and development in the pharmaceutical industry. In High Throughput Analysis in the Pharmaceutical Industry. P. G. Wang, Ed. CRC Press, Boca Raton, FL, 2009, pp. 247-278.
30. S. Görög. Drug safety, drug quality, drug analysis. J. Pharm. Biomed. Anal. 48:247-253 (2008).
31. R. LoBrutto and T. Patel. Method validation. In HPLC for Pharmaceutical Scientists. Y Kazakevich and R. LoBrutto, Eds. John Wiley & Sons, New Jersey, 2007, pp. 455-502.
32. B. Dejaegher, Y. V. Heyden. Ruggedness and robustness testing. J. Chromatogr. A 1158:138-157 (2007).
33. M. Zeaiter, J.-M. Roger, V. Bellon-Maurel, and D. N. Rutledge. Robustness of models developed by multivariate calibration. Part I: The assessment of robustness. Trends Anal. Chem. 23:157-170 (2004).
34. P. Barmpalexis, F. I. Kanaze, and E. Georgarakis. Developing and optimizing a validated isocratic reversed-phase high-performance liquid chromatography separation of nimodipine and impurities in tablets using experimental design methodology. J. Pharm. Biomed. Anal. 49:1192-1202 (2009).
35. 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. J. Chromatogr. A 987:57-66 (2003).