Development and validation of a direct enantiomeric separation of pregabalin to support isolated perfused rat kidney studies

Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences

Volumn 875, Issue 1, 2008, Pages 148-153

  Zhang, Yizhong ^a   Holliman, Christopher ^a   Tang, Daniel ^a   Fast, Douglas ^a   Michael, Steven ^a  

^a PFIZER INC   (United States)

Author keywords

Chiral separation; HPLC MS MS; Pregabalin; Validation

Indexed keywords

AMINES; AMINO ACIDS; CHIRALITY; CHROMATOGRAPHIC ANALYSIS; ENANTIOMERS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; ORGANIC ACIDS; SEPARATION;

BASELINE RESOLUTIONS; CHIRAL SEPARATION; CHIRAL SEPARATIONS; DIRECT ENANTIOMERIC SEPARATIONS; FIBROMYALGIA; HPLC/MS/MS; MACROCYCLIC GLYCOPEPTIDE; PARTIAL SEPARATIONS; PREGABALIN; RAT KIDNEYS; RAT URINES; STATIONARY PHASES; VALIDATION;

ISOMERS;

GLYCOPEPTIDE; PREGABALIN; SOLVENT;

ANIMAL TISSUE; ARTICLE; CALIBRATION; CHIRALITY; DRUG ISOLATION; DRUG METABOLISM; ENANTIOMER; ENANTIOSELECTIVITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; IONIC STRENGTH; ISOLATED KIDNEY; ISOMER; KIDNEY PERFUSION; MASS SPECTROMETRY; NONHUMAN; PH; PHASE SEPARATION; PRIORITY JOURNAL; RAT; SENSITIVITY AND SPECIFICITY; STANDARD; ULTRAFILTRATION; URINALYSIS; VALIDATION PROCESS;

ANIMALS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; GAMMA-AMINOBUTYRIC ACID; HYDROGEN-ION CONCENTRATION; KIDNEY; OSMOLAR CONCENTRATION; RATS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; STEREOISOMERISM;

RATTUS;

EID: 54149086689     PISSN: 15700232     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jchromb.2008.07.042     Document Type: Article

References (31)

1. Taylor C., Angelotti T., and Fauman E. Epilepsy Res. 73 (2007) 137
2. Pfizer website for Lyrica, http://www.lyrica.com/.
3. FDA website for Fibromyalgia, http://www.fda.gov/consumer/updates/fibromyalgia062107.html.
4. Gee N.S., Brown J.P., Dissanayake V.U., Offord J., Thurlow R., and Woodruff G.N. J. Biol. Chem. 271 (1996) 5768
5. Taylor C.P., Vartanian M.G., Yuen P.W., Bigge C., Suman-Chauhan N., and Hill D.R. Epilepsy Res. 14 (1993) 11
6. Berry D., and Millington C. Ther. Drug Monit. 27 (2005) 451
7. Vermeij T.A.C., and Edelbroek P.M. J. Chromatogr. B 810 (2004) 297
8. Windsor B.L., and Radulovic L. J. Chromatogr. B 674 (1995) 143
9. Vaidya V.V., Yetal S.M., Roy S., Gomes N.A., and Joshi S.S. Chromatographia 66 (2007) 925
10. Taft D.R. Curr. Drug Discov. Technol. 1 (2004) 97
11. Loutzenhiser R.D., Epstein M., and Nephrol S. J. Cardiovasc. Pharmacol. 12 (1988) 48
12. Maack T. Kidney Int. 30 (1986) 142
13. Pagel H. J. Oncol. Pharm. Pract. 4 (1998) 218
14. Lepsy C.S., Guttendorf R.J., Kugler A.R., and Smith D.E. Antimicrob. Agents Chemother. 47 (2003) 689
15. Lindner W. Mikrochim. Acta II (1991) 113
16. Chen X., Zhang D., Deng J., and Fu X. J. Chromatogr. Sci. 46 (2008) 42
17. Pfizer Internal Standard Test Procedure: Pregabalin API Identification and Chiral Purity by HPLC, Pfizer Inc., 2004
18. Jadhav A.S., Pathare D.B., and Shingare M.S. Chromatographia 65 (2007) 253
19. D. Zhang, X. Fu, M. Zhuge, J.Cai, B. Fan, Chinese Patent CN 1786703A (2006) 0614.
20. Armstrong D.W., Tang Y., Chen S., Zhou Y., Bagwill C., and Chen J.R. Anal. Chem. 66 (1994) 1473
21. Ward T.J., Dann III C., and Blaylock A. J. Chromatogr. A 715 (1995) 337
22. Armstrong D.W., Rundlett K.L., and Chen J.R. Chirality 6 (1994) 496
23. Armstrong D.W., Liu Y.B., and Ekborg-Ott K.H. Chirality 7 (1995) 474
24. Rundlett K.L., Gasper M.P., Zhou E.Y., and Armstrong D.W. Chirality 8 (1996) 88
25. Gasper M.P., Berthod A., Nair U.B., and Armstrong D.W. Anal. Chem. 68 (1996) 2501
26. Berthod A., Liu Y.B., Bagwill C., and Armstrong D.W. J. Chromatogr. A 731 (1996) 123
27. Chen S. J. Chin. Chem. Soc. 49 (2002) 545
28. Peter A., Arki A., Tourwe D., Forro E., Fueloep F., and Armstrong D.W. J. Chromatogr. A 1031 (2004) 159
29. Peter A., Toeroek R., and Armstrong D.W. J. Chromatogr. A 1057 (2004) 229
30. Wang A.X., Lee J.T., and Beesley T.E. LCGC 18 (2000) 626
31. Advanced Separation Technologies Inc., A Guide to Using Macrocyclic Glycopeptide bonded phases for Chiral LC Separations, 4th edition, 2002.