Comparative study of different approaches to the determination of robustness for a sensitive-stacking capillary electrophoresis method. Estimation of system suitability test limits from the robustness test

Analytical and Bioanalytical Chemistry

Volumn 389, Issue 2, 2007, Pages 541-553

  Galeano Díaz, Teresa ^a   Acedo Valenzuela, María Isabel ^a   Mora Díez, Nielene ^a   Silva Rodríguez, Antonio ^a  

^a UNIVERSITY OF EXTREMADURA   (Spain)

Author keywords

Plackett Burman design; Robustness test; Sensitive stacking capillary electrophoresis method; System suitability test limits

Indexed keywords

ACETONITRILE; ALGORITHMS; AMINES; PH EFFECTS; SODIUM CHLORIDE; STATISTICAL METHODS;

PLACKETT BURMAN DESIGN; ROBUSTNESS TESTS; SENSITIVE STACKING CAPILLARY ELECTROPHORESIS METHOD; SYSTEM SUITABILITY TEST LIMITS;

CAPILLARY ELECTROPHORESIS;

EID: 34548282095     PISSN: 16182642     EISSN: 16182650     Source Type: Journal    
DOI: 10.1007/s00216-007-1446-1     Document Type: Article

References (25)

1. ICH (2005) ICH harmonised tripartite guideline. Validation of analytical procedures. Text and methodology Q2(R1). http://www.ich.org/LOB/media/MEDIA417. pdf. Cited 26 Apr 2007
2. Vander Heyden Y, Luypaert K, Hartmann C, Massart D, Hoogmartens J, De Beer J (1995) Anal Chim Acta 312:245-262
3. Green JM (1996) Anal Chem 68:305A-309A
4. Nijhuis A, van der Knaap HCM, de Jong S, Vandeginste BGM (1999) Anal Chim Acta 391:187-202
5. United States Pharmacopeia Convention (1995) The United States Pharmacopeia USP XXIII. Validation of compendial method. United States Pharmacopeia Convention, Rockville
6. Swartz M, Krull I (2006) LCGC North Am 24:480-490
7. Vander Heyden Y, Questier F, Massart DL (1998) J Pharm Biomed Anal 18:43-56
8. Youden WJ, Steiner EH (1975) Statistical manual of the Association of Official Analytical Chemists. The Association of Official Analytical Chemists, Arlington, pp 70-71, 82-83
9. Vander Heyden Y, Jimidar M, Hund E, Niemeijier N, Peeters R, Smeyers-Verbeke J, Massart DL, Hoogmartens J (1999) J Chromatogr A 845:145-154
10. Fabre H (1996) J Pharm Biomed Anal 14:1125-1132
11. Dadgar D, Burnett PE, Choc MG, Gallicano K, Hooper JW (1995) J Pharm Biomed Anal 13:89-97
12. Morgan E (1991) Chemometrics: experimental design, analytical chemistry by open learning. Wiley, Chichester, pp 118-188
13. Box G, Hunter W, Hunter J (1978) Statistics for experiments, an introduction to design, data analysis and model building. Wiley, New York, pp 306-418
14. Vander Heyden Y, Massart DL (1996) In: Hendriks MMWB, de Boer JH, Smilde AK (eds) Robustness of analytical methods and pharmaceutical technological products. Elsevier, Amsterdam, pp 79-147
15. Plackett RL, Burman JP (1946) Biometrika 33:305-325
16. Fabre H, Mesplet N (2000) J Chromatogr A 897:329-338
17. Dong F (1993) Stat Sin 3:209-217
18. Vander Heyden Y, Nijhuis A, Smeyers-Verbeke J, Vandeginste BGM, Massart DL (2001) J Pharm Biomed Anal 24:723-753
19. Cuadros Rodríguez L, Blanc García R, García Campaña AM, Bosque-Sendra JM (1998) Chemom Intell Lab Syst 41:57-68
20. Bosque-Sendra JM, Nechar M, Cuadros Rodríguez L (1999) Fresenius J Anal Chem 365:480-488
21. Galeano Díaz T, Acedo Valenzuela MI, Mora Díez N, Silva Rodríguez A (2005) Electrophoresis 26:3518-3527
22. Jones K (1986) Int Lab 16:32-45
23. King EP (1958) J Am Stat Assoc 48:531
24. Massart DL, Vandeginste BGM, Buydens LMC, De Jong S, Lewi PJ, Smeyers-Verbeke J (1997) Handbook of chemometrics and qualimetrics: part A. Elsevier, Amsterdam
25. Camo Software (1996) The Unscrambler, version 6.11. CAMO Software, Trondheim