Capillary electrophoresis method validation

H. Watzig, M. Degenhardt, and A. Kunkel, Strategies for capillary electrophoresis Method development and validation for pharmaceutical and biological applications, Electrophoresis, 19, 2695 (1998). 

Tim Wehr is Staff Scientist at Bio-Rad Laboratories in Hercules, California. He has more than 20 years of experience in biomolecule separations, including development of HPLC and capillary electrophoresis methods and instrumentation for separation of proteins, peptides, amino acids, and nucleic acids. He has also worked on development and validation of LC-MS methods for small molecules and biopharmaceuticals. He holds a B.S. degree from Whitman College, Walla Walla, Washington, and earned his Ph.D. from Oregon State University in Corvallis. 

Hammitzsch, M., Rao, R. N., and Scriba, G. K. E. (2006). Development and validation of a robust capillary electrophoresis method for impurity profiling of etomidate including the determination of chiral purity using a dual cyclodextrin system. Electrophoresis 27(21), 4334—4344. 

Marini, R. D., Servais, A.-C., Rozet, E., Chiap, P., Boulanger, B., Rudaz, S., Crommen, J., Hubert, P., and Fillet, M. (2006). Nonaqueous capillary electrophoresis method for the enantiomeric purity determination of 5-timolol using heptakis(2,3-di-0-methyl-6-0-sulfo)-p-cyclodextrin validation using the accuracy profile strategy and estimation of uncertainty. /. Chromatogr. A 1120(1—2), 102-111. 

Muijselaar, P. G., hammers, N. G. E M., and Gerding, T. K. (2004). Development and validation of a capillary electrophoresis method for the enantiomeric purity determination of SLV307, a basic potential antipsychotic compound. Electrophoresis 25(16), 2854—2859. 

Sanger-van de Griend, C. E., Wahlstrom, H., Groningsson, K., and Widahl-Nasman, M. (1997). A chiral capillary electrophoresis method for ropivacaine hydrochloride in pharmaceutical formulations validation and comparison with chiral liquid chromatography. /. Pharm. Biomed. Anal. 15(8), 1051-1061. 

Toro, L, Dulsat, J. E, Fabregas, J. L., and Claramunt, J. (2004). Development and validation of a capillary electrophoresis method with ultraviolet detection for the determination of the related substances in a pharmaceutical compound. /. Chromatogr. A 1043(2), 303 — 315. 

Jamali, B., and Lehmann, S. (2004). Development and validation of a high-resolution capillary electrophoresis method for multi-analysis of ragaglitazar and arginine in active pharmaceutical ingredients and low-dose tablets. /. Pharm. Biomed. Anal. 34(3), 463—472. 

Wynia, G. S., Windhorst, G., Post, P. C., and Maris, F. A. (1997). Development and validation of a capillary electrophoresis method within a pharmaceutical quality control environment and comparison with high-performance liquid chromatography. /. Chromatogr. A 773(1—2), 339—350. 

Eurlanetto, S., Orlandini, S., Massolini, G., Faucci, M. T., La Porta, E., and Pinzauti, S. (2001). Optimisation and validation of a capillary electrophoresis method for the simultaneous determination of diazepam and otilonium bromide. Analyst 126(10), 1700-1706. 

Cherkaoui, S., Daali, Y., Christen, R, and Veuthey, J.-L. (1998). Development and validation of liquid chromatography and capillary electrophoresis methods for acarbose determination in pharmaceutical tablets. J. Pharm. Biomed. Anal. 18(4 —5), 729 — 735. 

Perez-Ruiz, T., Martinez-Lozano, C., and Galera, R. (2006). Development and validation of a capillary electrophoresis method with laser-induced fluorescence detection for the determination of captopril in human urine and pharmaceutical preparations. Electrophoresis 27(12), 2310—2316. 

Altria, K. D., Wood, T, Kitscha, R., and Roberts-Mcintosh, A. (1995). Validation of a capillary electrophoresis method for the determination of potassium counter-ion levels, in an acidic drug salt. /. Pharm. Biomed. Anal. 13(1), 33 — 38. 

Toasaksiri, S., Massart, D. L., and Vander Heyden, Y. (2000). Study of method validation criteria in a capillary electrophoresis method for the separation of non-steroidal anti-inflammatory drugs. Anal. Chim. Acta 416, 29-42. 

Watzig, H., Degenhardt, M., and Kunkel, A. (1999). Strategies for capillary electrophoresis method development and validation for pharmaceutical and biological application. Electrophoresis 19, 2695-2742. 

Kaale, E., Van Schepdael, A., Roets, E., and Hoogmartens, J. (2002). Development and validation of capillary electrophoresis method for tobramycin with precapillary derivatization and UV detection. 

Thomas, B. R., and Ghodbane, S. (1993). Evaluation of a mixed micellar electrokinetic capillary electrophoresis method for validated pharmaceutical quality-control. /. Liq. Chromatogr. 16, 1983-2006. 

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