Liquid chromatographic separation of pregabalin and its possible impurities with fluorescence detection after postcolumn derivatization with o-phtaldialdehyde

Journal of Pharmaceutical and Biomedical Analysis

Volumn 53, Issue 3, 2010, Pages 717-722

  Douša, Michal ^a   Gibala, Petr ^a   Lemr, K ^b,c  

^a Zentiva Prague   (Czech Republic)

^b PALACKÝ UNIVERSITY   (Czech Republic)

^c INSTITUTE OF MICROBIOLOGY   (Czech Republic)

Author keywords

HPLC; Phamaceutical formulation; Postcolumn derivatization; Pregabalin; Reversed phase separation; Validation

Indexed keywords

ALDEHYDE DERIVATIVE; MERCAPTOETHANOL; PREGABALIN;

ARTICLE; DRUG IMPURITY; ELUTION; FLUORESCENCE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PRIORITY JOURNAL; SEPARATION TECHNIQUE; SPECTRAL SENSITIVITY; TABLET;

CALIBRATION; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG CONTAMINATION; GAMMA-AMINOBUTYRIC ACID; LIMIT OF DETECTION; O-PHTHALALDEHYDE; SENSITIVITY AND SPECIFICITY; SPECTROMETRY, FLUORESCENCE;

EID: 77954860748     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2010.04.008     Document Type: Article

References (34)

1. Patsalos P.N. New antiepileptic drugs. Ann. Clin. Biochem. 1999, 36:10-19.
2. Bialer M., Johannesen S.I., Kupferberg H.J., Levy R.H., Loiseau P., Perucca E. Progress report on new antiepileptic drugs: a summary of the fourth Eilat conference. Epilepsy Res. 1999, 34:1-34.
3. Patent EP0 828 704B1, Claim 9h, European Patent Office, 1996.
4. Moore S., Stein W.H. Chromatography of amino acids on sulfonated polystyrene resins. J. Biol. Chem. 1951, 192:663-681.
5. Pfeifer R.F., Hill D.W. High performance liquid chromatography of amino acids: ion-exchange and reversed-phase strategies. Adv. Chromatogr. 1983, 22:37-69.
6. Hancock W.S., Bishop C.A., Hearn M.T.W. The analysis of nanogram levels of free amino acids by reverse-phase high pressure liquid chromatogramy. Anal. Biochem. 1979, 92:170-173.
7. Frey J., Chamson A., Raby A.N. Separation of amino acids using ion-paired reversed phase high performance liquid chromatography with special reference to collagen hydrolysate. Amino Acids 1993, 4:45-51.
8. Candella M., Ruiz A., Feo F.J. Validation of an analysis method for 4-amino-3-hydroxybutyric acid by reversed-phase liquid chromatography. J. Chromatogr. A 2000, 890:273-280.
9. Petritis K., Chaimbault P., Elfakir C., Dreux M. Ion-pair reversed-phase liquid chromatography for determination of polar underivatized amino acids using perfluorinated carboxylic acids as ion pairing agent. J. Chromatogr. A 1999, 833:147-155.
10. Petritis K., Elfakir C., Dreux M. A comparative study of commercial liquid chromatographic detectors for the analysis of underivatized amino acids. J. Chromatogr. A 2002, 961:9-21.
11. Yan D., Li G., Xiao X.-H., Dong X.-P., Li Z.-L. Direct determination of fourteen underivatized amino acids from Whitmania pigra by using liquid chromatography-evaporative light scattering detection. J. Chromatogr. A 2007, 1138:301-304.
12. Qu J., Wang Y., Luo G.A., Wu Z., Yang C. Validated quantitation of underivatized amino acids in human blood samples by volatile ion-pair reversed-phase liquid chromatography coupled to isotope dilution tandem mass spectrometry. Anal. Chem. 2002, 74:2034-2040.
13. Kwon J.Y., Moini M. Analysis of underivatized amino acid mixtures using high performance liquid chromatography/dual oscillating nebulizer atmospheric pressure microwave induced plasma ionization-mass spectrometry. J. Am. Soc. Mass Spectrom. 2001, 12:117-122.
14. Petritis K., Person M., Elfakir C., Dreux M. Validation of an ion-interaction chromatography analysis of underivatized amino acids in commercial preparation using evaporative light scattering detection. Chromatographia 2004, 60:293-298.
15. Casella I.G., Contursi M. Isocratic ion chromatographic determination of underivatized amino acids by electrochemical detection. Anal. Chim. Acta 2003, 478:179-185.
16. Yu H., Ding Y.-S., Mou S.F. Some factors affecting separation and detection of amino acids by high-performance anion-exchange chromatography with integrated pulsed aperometric detection. J. Chromatogr. A 2003, 997:145-153.
17. Fujita K., Nagatsu T., Maruta K., Teradaira R., Beppu H., Tsujt Y., Kato T. Fluorescence assay for dopamine β-hydroxylase activity in human serum by high-performance liquid chromatogramy. Anal. Biochem. 1977, 82:130-140.
18. Hughes G.J., Winterhalter K.H., Boller E., Wilson K.J. Amino acid analysis using standard high-performance liquid chromatography equipment. J. Chromatogr. 1982, 235:417-426.
19. Undenfriend S., Stein S., Bohlen P., Dairman W. A reagent for assay of amino acids, peptides, proteins, and primary amines in the picomole range. Science 1972, 237:871-872.
20. Roth M. Fluorescence reaction for amino acids. Anal. Chem. 1971, 43:880-882.
21. Simons S.S., Johnson D.F. The structure of the fluorescent adduct formed in the reaction of o-phthalaldehyde and thiols with amines. J. Am. Chem. Soc. 1976, 98:7098-7099.
22. Roth M., Hampai A. Column chromatography of amino acids with fluorescence detection. J. Chromatogr. 1973, 83:353-356.
23. Vaidya V.V., Yetal S.M., Roy S.M.N., Gomes N.A., Joshi S.S. LC-MS-MS determination of pregabalin in human plasma. Chromatographia 2007, 66:925-928.
24. Mandal U., Sarkar A.K., Gowda K.V., Agarwal S., Bose A., Bhaumik U., Ghosh D., Pal T.K. Determination of pregabalin in human plasma using LC-MS-MS. Chromatographia 2008, 67:237-243.
25. Vermeij T.A.C., Edelbroek P.M. Simultaneous high-performance liquid chromatographic analysis of pregabalin, gabapentin and vigabatrin in human serum by precolumn derivatization with o-phtaldialdehyde and fluorescence detection. J. Chromatogr. B 2004, 810:297-303.
26. Berry D., Millington C. Analysis of pregabalin at therapeutic concentrations in human plasma/serum by reversed-phase HPLC. Ther. Drug Monit. 2005, 27:451-456.
27. Jadhav A.S., Pathare D.B., Shingare M.S. Validated enantioselective LC method, with precolumn derivatization with Marfey's reagent, for analysis of the antiepileptic drug pregabalin in bulk drug samples. Chromatographia 2007, 65:253-256.
28. Chen X., Zhang D., Deng J., Fu X. Determination of optical impurity of pregabalin by HPLC with pre-column chiral derivatization. J. Chromatogr. Sci. 2008, 46:42-44.
29. Berendsen G.E., Galan L.L. Role of the chain length of chemically bonded phases and the retention mechanism in reversed-phase liquid chromatography. J. Chromatogr. 1980, 196:21-37.
30. Valko K., Snyder L.R. Retention in reversed-phase liquid chromatography as a function of mobile-phase composition. J. Chromatogr. A 1993, 656:501-520.
31. Melander W.R., Mannan C.A., Horvath Cs. Mobile phase effects in reversed-phase chromatography. IV. Retention by n-alkylbenzenes as a function of column temperature and the nature and concentration of organic co-solvent. Chromatographia 1982, 15:611-615.
32. Colin H., Guiochon G. Comparison of some packings for reversed-phase high-performance liquid-solid chromatography. II. Some theoretical considerations. J. Chromatogr. 1978, 158:183-205.
33. ICH Q2(R1), Validation of Analytical Procedures, Step 4 Version, 2005.
34. Van Loco J., Elskens M., Croux Ch., Beernaert H. Linearity of calibration curves: use and misuse of the correlation coefficient. Accredit. Qual. Assur. 2002, 7:281-285.