LC method for the therapeutic drug monitoring of lamotrigine: Evaluation of the assay performance and validation of its application in the routine area

Journal of Pharmaceutical and Biomedical Analysis

Volumn 49, Issue 2, 2009, Pages 547-553

  Zufia L ^a   Aldaz, A ^a   Ibanez N ^a   Viteri, C ^a  

^a Universidad Pública de Navarra   (Spain)

Author keywords

Accuracy profile; HPLC; Lamotrigine; Therapeutic drug monitoring; Validation

Indexed keywords

3,5 DIAMINO (6 METHOXYPHENYL) 1,2,4 TRIAZINE; LAMOTRIGINE; TRIAZINE DERIVATIVE; UNCLASSIFIED DRUG;

ACCURACY; ANALYTIC METHOD; ARTICLE; CONCENTRATION (PARAMETERS); DRUG BLOOD LEVEL; DRUG MONITORING; HUMAN; LIQUID CHROMATOGRAPHY; MEASUREMENT; PRIORITY JOURNAL; QUALITY CONTROL; RELIABILITY; SOLID PHASE EXTRACTION; STANDARD; VALIDATION PROCESS;

ANTICONVULSANTS; BIOLOGICAL ASSAY; CHROMATOGRAPHY, LIQUID; DRUG MONITORING; HUMANS; LOGISTIC MODELS; QUALITY CONTROL; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SOLID PHASE EXTRACTION; SPECTROPHOTOMETRY, ULTRAVIOLET; TIME FACTORS; TRIAZINES;

EID: 59049085221     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2008.11.030     Document Type: Article

References (47)

1. Brodrie M.J. Lancet 339 (1993) 1397
2. Goa K.L., Ross S.R., and Chrisp P. Drugs 46 (1993) 152
3. Messenheimer J.A. Epilepsia 36 Suppl. 2 (1995) 87
4. Kepetanovic I.M. J. Chromatogr. 531 (1990) 421
5. Eadie M.J. Br. J. Clin. Pharmacol. 46 (1998) 185
6. Perucca E. Clin. Pharmacokinet. 38 (2000) 191
7. Tomson T., and Johannssen S. Eur. Clin. Pharmacol. 55 (2000) 697
8. Yukawa E. Clin. Pharmacokinet. 31 (1996) 120
9. Johannssen S.I. CNS Drugs 7 (1997) 349
10. Schumacher G.E. Therapeutic Drug Monitoring (1995), Appleton and Lange, Norwalk, CT, USA
11. May T.W., Rambeck B., and Jürgens U. Ther. Drug Monit. 18 (1996) 523
12. Morris R.G., Black A.B., Harris A.L., Batty A.B., and Sallustio B.C. Br. J. Clin. Pharmacol. 46 (1998) 547
13. Bottiger Y., Svensson J.O., and Stahle L. Ther. Drug Monit. 21 (1999) 171
14. Chan V., Morris R.G., Ilett K.F., and Tett S.E. Ther. Drug Monit. 23 (2001) 630
15. Morris R.G., Black A.B., Lam E., and Westley I.A. Ther. Drug Monit. 22 (2000) 656
16. Shihabi Z.K., and Oles K.S. J. Chromatogr. B 683 (1996) 119
17. Yuen A.W.C., Land G., Weatherley B.C., and Peck A.W. Br. J. Clin. Pharmacol. 33 (1992) 511
18. Fazio A., Artesi C., Russo M., Trio R., Oteri G., and Pisani F. Ther. Drug Monit. 14 (1992) 509
19. Yamashita S., Furuno K., Kawasaki H., Gomita Y., Yoshinaga H., Yamatogi Y., and Ohtahara S. J. Chromatogr. B 670 (1995) 454
20. Bartoli A., Marchiselli R., and Gatti G. Ther. Drug Monit. 19 (1997) 100
21. Hart A.P., Mazarr-Proo S., Blackwell W., and Dasgupta A. Ther. Drug Monit. 19 (1997) 431
22. Ren S., Scheurer M.L., and Zheng W. Ther. Drug Monit. 20 (1998) 209
23. Angelis-Stoforidis P., Morgan D.J., ÓBrien T.J., and Vajda F.J.E. J. Chromatogr. B 727 (1999) 113
24. Croci D., Salmaggi A., de Grazia U., and Bernardi G. Ther. Drug Monit. 23 (2001) 665
25. Theurillat R., Kuhn M., and Thormann W. J. Chromatogr. A 979 (2002) 368
26. Biddlecombe R.A., Dean K.L., Smith C.D., and Jeal S.C. J. Pharm. Biomed. Anal. 8 (1990) 691
27. Sailstad J.M., and Findlay J.W.A. Ther. Drug Monit. 13 (1991) 433
28. Boulanger B., Chiap P., Dewé W., Crommen J., and Hubert Ph. J. Pharm. Biomed. Anal. 32 (2003) 753
29. Hubert Ph., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.A., Dewé W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzart G., Nivet C., and Valat L. S.T.P. Pharma Pratiques 13 (2003) 101
30. Hubert Ph., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.A., Dewé W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., and Valat L. J. Pharm. Biomed. Anal. 36 (2004) 579
31. Hubert Ph., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.A., Dewé W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., Valat L., and Rozet E. J. Pharm. Biomed. Anal. 45 (2007) 70
32. Hubert Ph., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Cohen N., Compagnon P.A., Dewé W., Feinberg M., Laurentie M., Mercier N., Muzard G., Valat L., and Rozet E. J. Pharm. Biomed. Anal. 45 (2007) 82
33. Hubert Ph., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Cohen N., Compagnon P.A., Dewé W., Feinberg M., Laurentie M., Mercier N., Muzard G., Valat L., and Rozet E. J. Pharm. Biomed. Anal. 48 (2008) 760
34. Bugamelli F., Sabbioni C., Mandrioli R., Kenndler E., Albani F., and Raggi M.A. Anal. Chem. Acta 472 (2002) 10
35. Watelle M., Demedts P., Franck F., de Deyn P.P., Wauters A., and Neels H. Ther. Drug Monit. 19 (1997) 460
36. Fraser A.D., MacNeil W., Isner A.F., and Camfield P.R. Ther. Drug Monit. 17 (1995) 174
37. Cohen A.F., Land G.S., Breimer D.D., Yuen W.C., Winton C., and Peck A.W. Clin. Pharmacol. Ther. 42 (1987) 535
38. Posner J., Cohen A.F., Land G., Winton C., and Peck A.W. Br. J. Clin. Pharmacol. 28 (1989) 117
39. Meyler M., Kelly M.T., and Smyth M.R. Chromatographia 36 (1993) 27
40. Saracino M.A., Bugamelli F., Conti M., Amore M., and Raggi M.A. J. Sep. Sci. 30 (2007) 2249
41. Gonzalez G., and Herrador M.A. Talanta 70 (2006) 901
42. Guidance for industry: Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), May 2001.
43. Shah V.P., Midha K.K., Dighe S., MacGilveray I.J., Skelly J.P., Yacobi A., Layloff T., Viswanathan C.T., Cook C.E., MacDowall R.D., Pittman K.A., and Spector S. J. Pharm. Sci. 81 (1992) 309
44. Shah V.P., Midha K.K., Findlay J.W.A., Hill H.M., Hulse J.D., MacGilveray I.J., McKay G., Miller K.J., Patnaik R.N., Powell M.L., Tonelli A., Viswanathan C.T., and Yacobi A. Pharm. Res. 17 (2000) 1551
45. ISO5725-1, Application of the statistics-accuracy (trueness and precision) of the results and methods of measurement: Part 1, General principles and definitions, International Organization for Standardisation (ISO), Geneva, Switzerland.
46. Shah V.P., Midha K.K., Dighe S., McGilveray I.J., Skelly J.P., Yacobi A., Layloff T., Viswanathan C.T., Cook C.E., McDOwal R.D., Pittman K.A., and Spector S. Pharm. Res. 9 (1992) 588
47. Mee R. Commun. Stat. Theory Method 17 (1988) 1465