Assessment of liquid chromatographic method robustness by use of Plackett-Burman design

Acta Chromatographica

Volumn 22, Issue 2, 2010, Pages 281-296

  Maskovic M ^a   Jancic Stojanovic B ^b   Malenovic A ^b   Ivanovic D ^b   Medenica, M ^b  

^a Medicines and Medical Devices Agency of Serbia   (Serbia)

^b Faculty of Pharmacy   (Serbia)

Author keywords

Impurities; Liquid chromatography; Perindopril tert butylamine; Plackett Burman design; Robustness; System suitability tests

Indexed keywords

EID: 77952962987     PISSN: 12332356     EISSN: 20835736     Source Type: Journal    
DOI: 10.1556/AChrom.22.2010.2.10     Document Type: Article

References (18)

1. Y. Vander Heyden, F. Questier, and D.L. Massart, J. Pharm. Biomed. Anal., 18 , 43 (1998)
2. B. Dejaegher, M. Dumarey, X. Capron, M.S. Bloomfield, and Y. Vander Heyden, Anal. Chim. Acta, 595 , 59 (2007)
3. T. Galeano-Diaz, M.I. Acedo-Valenzuela, N. Mora-Diez, and A. Silva-Rodriguez, Anal. Bioanal. Chem., 389 , 541 (2007)
4. Y. Vander Heyden, A. Nijhuis, J. Smeyers-Verbeke, B.G.M. Vandeginste, and D.L. Massart, J. Pharm. Biomed. Anal., 24 , 723 (2001)
5. A. Nijhuis, H.C.M. van der Knaap, S. de Jong, and B.G.M. Vandeginste, Anal. Chim. Acta, 391 , 187 (1999)
6. R.D. Marini, E. Rozet, Y. Vander Heyden, E. Ziemons, B. Boulanger, A. Bouklouze, A.C. Servais, M. Fillet, J. Crommen, and P. Hubert, J. Pharm. Biomed. Anal., 44 , 640 (2007)
7. H. Fabre, J. Pharm. Biomed. Anal., 14 , 1125 (1996)
8. Y. Vander Heyden, S. Kuttatharmmakul, J. Smeyers-Verbeke, and D.L. Massart, Anal. Chem., 72 , 2869 (2000)
9. E. Hund, Y. Vander Heyden, M. Haustein, D.L. Massart, and J. Smeyers-Verbeke, J. Chromatogr. A, 874 , 167 (2000)
10. R. Ragonese, M. Mulholland, and J. Kalman, J. Chromatogr. A, 870 , 45 (2000)
11. R. Ficarra, P. Ficarra, S. Tommasini, S. Melardi, M.L. Calabro, S. Furlanetto, and M. Semreen, J. Pharm. Biomed. Anal., 23 , 169 (2000)
12. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use, Topic Q2(R1), Validation of Analytical Procedures: Text and Methodology. http://www.ich.org (access date July, 2009)
13. European Pharmacopoeia, 6th edn, 2008, Council of Europe, Strasbourg
14. N. Erk, J. Pharm. Biomed. Anal., 26 , 43 (2001)
15. A. Gumieniczek and H. Hopkala, Chem. Anal. (Warsaw), 43 , 951 (1998)
16. M. Medenica, D. Ivanović, M. Mašković, B. Janćić and A. Malenović, J. Pharm. Biomed. Anal., 44 , 1087 (2007)
17. B. Dejaegher, X. Capron, J. Smeyers-Verbeke, and Y. Vander Heyden, Anal. Chim. Acta, 564 , 184 (2006)
18. M. Zeaiter, J.M. Roger, V. Bellon-Maurel, and D.N. Rutledge, Trends Anal. Chem., 23 , 157 (2004)