Quantification of lamotrigine in patient plasma using a fast liquid chromatography-tandem mass spectrometry method with backflush technology

Therapeutic Drug Monitoring

Volumn 37, Issue 2, 2015, Pages 188-197

  Wong, Jessica M ^a   Jones, Jace W ^a   Jiang, Wenlei ^b   Polli, James E ^a   Kane, Maureen A ^a  

^a UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

backflush; bioequivalence; fast LC; high performance liquid chromatography; human plasma; lamotrigine; pharmacokinetics; quantification; tandem mass spectrometry

Indexed keywords

CARBAMAZEPINE; ETIRACETAM; HARKOSERIDE; LAMOTRIGINE; PHENYTOIN; PROTEIN; STABLE ISOTOPE; TOPIRAMATE; ANTICONVULSIVE AGENT; TRIAZINE DERIVATIVE;

ANALYTIC METHOD; ARTICLE; BACKFLUSH METHOD; CALIBRATION; CLINICAL ARTICLE; DILUTION; DRUG STABILITY; ELECTROSPRAY; FREEZE THAWING; HUMAN; ISOTOPE LABELING; LIMIT OF DETECTION; LIMIT OF QUANTITATION; LIQUID CHROMATOGRAPHY; MEASUREMENT ACCURACY; PLASMA; PRECIPITATION; PRIORITY JOURNAL; REPRODUCIBILITY; STANDARD; STEADY STATE; TANDEM MASS SPECTROMETRY; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY; BLOOD; ELECTROSPRAY MASS SPECTROMETRY; PROCEDURES; SENSITIVITY AND SPECIFICITY; THERAPEUTIC EQUIVALENCE; VALIDATION STUDY;

ANTICONVULSANTS; CHROMATOGRAPHY, LIQUID; HUMANS; LIMIT OF DETECTION; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SPECTROMETRY, MASS, ELECTROSPRAY IONIZATION; TANDEM MASS SPECTROMETRY; THERAPEUTIC EQUIVALENCY; TRIAZINES;

EID: 84925844605     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0000000000000123     Document Type: Article

References (55)

1. Xu RN, Fan L, Rieser MJ, et al. Recent advances in high-throughput quantitative bioanalysis by LC-MS/MS. J Pharm Biomed Anal. 2007;44: 342-355.
2. Hsieh Y. HPLC-MS/MS in drug metabolism and pharmacokinetic screening. Expert Opin Drug Metab Toxicol. 2008;4:93-101.
3. Tiwari G, Tiwari R. Bioanalytical method validation: an updated review. Pharm Methods. 2010;1:25-38.
4. GlaxoSmithKline Product Info. Available at: http://us.gsk.com/products/assets/us-lamictal.pdf. Accessed August 20, 2012.
5. Sallustio BC, Morris RG. High-performance liquid chromatography quantitation of plasma lamotrigine concentrations: application measuring trough concentrations in patients with epilepsy. Ther Drug Monit. 1997; 19:688-693.
6. Ren S, Scheuer ML, Zheng W. Determination of lamotrigine in biologic materials by a simple and rapid liquid chromatographic method. Ther Drug Monit. 1998;20:209-214.
7. Barbosa NR, Midio AF. Validated high-performance liquid chromato-graphic method for the determination of lamotrigine in human plasma. J Chromatogr B Biomed Sci Appl. 2000;741:289-293.
8. Contin M, Balboni M, Callegati E, et al. Simultaneous liquid chromato-graphic determination of lamotrigine, oxcarbazepine monohydroxy derivative and felbamate in plasma of patients with epilepsy. J Chroma-togr B Analyt Technol Biomed Life Sci. 2005;828:113-117.
9. Heideloff C, Bunch DR, Wang S. A novel HPLC method for quantification of 10 antiepileptic drugs or metabolites in serum/plasma using a monolithic column. Ther Drug Monit. 2010;32:102-106.
10. Fazio A, Artesi C, Russo M, et al. A liquid chromatographic assay using a high-speed column for the determination of lamotrigine, a new antiep-ileptic drug, in human plasma. Ther Drug Monit. 1992;14:509-512.
11. Matar KM, Nicholls PJ, Bawazir SA, et al. A rapid liquid chromato-graphic method for the determination of lamotrigine in plasma. J Pharm Biomed Anal. 1998;17:525-531.
12. Cheng CL, Chou CH, Hu OY. Determination of lamotrigine in small volumes of plasma by high-performance liquid chromatography. J Chro-matogr B Analyt Technol Biomed Life Sci. 2005;817:199-206.
13. Cociglio M, Alric R, Bouvier O. Performance analysis of a reversed-phase liquid chromatographic assay of lamotrigine in plasma using solvent-demixing extraction. J Chromatogr. 1991;572:269-276.
14. Bartoli A, Marchiselli R, Gatti G. A rapid and specific assay for the determination of lamotrigine in human plasma by normal-phase HPLC. Ther Drug Monit. 1997;19:100-107.
15. Londero D, Lo Greco P. New micromethod for the determination of lamotrigine in human plasma by high-performance liquid chromatogra-phy. J Chromatogr B Biomed Sci Appl. 1997;691:139-144.
16. Angelis-Stoforidis P, Morgan DJ, O'Brien TJ, et al. Determination of lamotrigine in human plasma by high-performance liquid chromatogra-phy. J Chromatogr B Biomed Sci Appl. 1999;727:113-118.
17. Torra M, Rodamilans M, Arroyo S, et al. Optimized procedure for lamo-trigine analysis in serum by high-performance liquid chromatography without interferences from other frequently coadministered anticonvul-sants. Ther Drug Monit. 2000;22:621-625.
18. Croci D, Salmaggi A, de Grazia U, et al. New high-performance liquid chromatographic method for plasma/serum analysis of lamotrigine. Ther Drug Monit. 2001;23:665-668.
19. Patil KM, Bodhankar SL. Simultaneous determination of lamotrigine, phenobarbitone, carbamazepine and phenytoin in human serum by high-performance liquid chromatography. J Pharm Biomed Anal. 2005; 39:181-186.
20. Greiner-Sosanko E, Lower DR, Virji MA, et al. Simultaneous determination of lamotrigine, zonisamide, and carbamazepine in human plasma by high-performance liquid chromatography. Biomed Chromatogr. 2007; 21:225-228.
21. Brunetto R, Contreras Y, Delgado Y, et al. Development and validation of a rapid column-switching high-performance liquid chromatographic method for the determination of lamotrigine in human serum. J Chroma-togr Sci. 2009;47:478-484.
22. Ramachandran S, Underhill S, Jones SR. Measurement of lamotrigine under conditions measuring phenobarbitone, phenytoin, and carbamaze-pine using reversed-phase high-performance liquid chromatography at dual wavelengths. Ther Drug Monit. 1994;16:75-82.
23. Saracino MA, Bugamelli F, Conti M, et al. Rapid HPLC analysis of the antiepileptic lamotrigine and its metabolites in human plasma. J Sep Sci. 2007;30:2249-2255.
24. Zufia L, Aldaz A, Ibanez N, et al. LC method for the therapeutic drug monitoring of lamotrigine: evaluation of the assay performance and validation of its application in the routine area. J Pharm Biomed Anal. 2009; 49:547-553.
25. Cantu MD, Toso DR, Lacerda CA, et al. Optimization of solid-phase microextraction procedures for the determination of tricyclic antidepres-sants and anticonvulsants in plasma samples by liquid chromatography. Anal Bioanal Chem. 2006;386:256-263.
26. Watelle M, Demedts P, Franck F, et al. Analysis of the antiepileptic phenyltriazine compound lamotrigine using gas chromatography with nitrogen phosphorus detection. Ther Drug Monit. 1997;19:460-464.
27. Queiroz ME, Silva SM, Carvalho D, et al. Determination of lamotrigine simultaneously with carbamazepine, carbamazepine epoxide, phenytoin, phenobarbital, and primidone in human plasma by SPME-GC-TSD. J Chromatogr Sci. 2002;40:219-223.
28. Theurillat R, Kuhn M, Thormann W. Therapeutic drug monitoring of lamotrigine using capillary electrophoresis. Evaluation of assay performance and quality assurance over a 4-year period in the routine arena. J Chromatogr. 2002;979:353-368.
29. Zheng J, Jann MW, Hon YY, et al. Development of capillary zone electrophoresis-electrospray ionization-mass spectrometry for the determination of lamotrigine in human plasma. Electrophoresis. 2004;25:2033-2043.
30. Lancas FM, Sozza MA, Queiroz ME. Simultaneous plasma lamotrigine analysis with carbamazepine, carbamazepine 10, 11 epoxide, primidone, phenytoin, phenobarbital, and PEMA by micellar electrokinetic capillary chromatography (MECC). J Anal Toxicol. 2003;27:304-308.
31. Westley IS, Morris RG. Seradyn quantitative microsphere system lamo-trigine immunoassay on a Hitachi 911 analyzer compared with HPLC-UV. Ther Drug Monit. 2008;30:634-637.
32. Subramanian M, Birnbaum AK, Remmel RP. High-speed simultaneous determination of nine antiepileptic drugs using liquid chromatography-mass spectrometry. Ther Drug Monit. 2008;30:347-356.
33. Beck O, Ohman I, Nordgren HK. Determination of lamotrigine and its metabolites in human plasma by liquid chromatography-mass spectrom-etry. Ther Drug Monit. 2006;28:603-607.
34. Sorensen LK. Determination of acidic and neutral therapeutic drugs in human blood by liquid chromatography-electrospray tandem mass spec-trometry. Forensic Sci Int. 2011;206:119-126.
35. Marcelin-Jimenez G, Angeles Moreno AC, Mendoza-Morales L, et al. Development of an ultra-performance liquid chromatography-tandem mass spectrometry micromethod for quantification of lamotrigine in human plasma and its use in a bioequivalence trial. Bioanalysis. 2009;1:47-55.
36. Moser C, Zoderer D, Luef G, et al. Simultaneous online SPE-LC-MS/MS quantification of six widely used synthetic progestins in human plasma. Anal Bioanal Chem. 2012;403:961-972.
37. Kim KB, Seo KA, Kim SE, et al. Simple and accurate quantitative analysis of ten antiepileptic drugs in human plasma by liquid chromatography/tan-dem mass spectrometry. J Pharm Biomed Anal. 2011;56:771-777.
38. Tai SS, Yeh CY, Phinney KW. Development and validation of a reference measurement procedure for certification of phenytoin, phenobarbital, la-motrigine, and topiramate in human serum using isotope-dilution liquid chromatography/tandem mass spectrometry. Anal Bioanal Chem. 2011; 401:1915-1922.
39. Lee W, Kim JH, Kim HS, et al. Determination of lamotrigine in human serum by high-performance liquid chromatography-tandem mass spec-trometry. Neurol Sci. 2010;31:717-720.
40. Shah HJ, Subbaiah G, Patel DM, et al. Rapid quantification of lamotri-gine in human plasma by two LC systems connected with tandem MS. J Chromatogr Sci. 2010;48:375-381.
41. Hotha KK, Kumar SS, Bharathi DV, et al. Rapid and sensitive LC-MS/MS method for quantification of lamotrigine in human plasma: application to a human pharmacokinetic study. Biomed Chromatogr. 2012;26:491-496.
42. Kane MA, Folias AE, Wang C, et al. Quantitative profiling of endogenous retinoic acid in vivo and in vitro by tandem mass spectrometry. Anal Chem. 2008;80:1702-1708.
43. Lu W, Bennett BD, Rabinowitz JD. Analytical strategies for LC-MS-based targeted metabolomics. J Chromatogr B Analyt Technol Biomed Life Sci. 2008;871:236-242.
44. Shao C, Dowling TC, Haidar S, et al. Quantification of acyclovir in human plasma by ultra high-performance liquid chromatography-heated electrospray ionization-tandem mass spectrometry for bioequivalence evaluation. J Anal Bioanal Tech. 2012;3:1-6.
45. Tiller PR, Romanyshyn LA, Neue UD. Fast LC/MS in the analysis of small molecules. Anal Bioanal Chem. 2003;377:788-802.
46. Romanyshyn LA, Tiller PR. Ultra-short columns and ballistic gradients: considerations for ultra-fast chromatographic liquid chromatographic-tandem mass spectrometric analysis. J Chromatogr A. 2001;928:41-51.
47. Ayrton J, Plumb R, Leavens WJ, et al. Application of a generic fast gradient liquid chromatography tandem mass spectrometry method for the analysis of cytochrome P450 probe substrates. Rapid Commun Mass Spectrom. 1998;12:217-224.
48. Tiller PR, Romanyshyn LA. Implications of matrix effects in ultra-fast gradient or fast isocratic liquid chromatography with mass spec-trometry in drug discovery. Rapid Commun Mass Spectrom. 2002; 16:92-98.
49. Ismaiel OA, Zhang T, Jenkins R, et al. Determination of octreotide and assessment of matrix effects in human plasma using ultra high performance liquid chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2011;879:2081-2088.
50. FDA. Guidance for Industry: Bioanalytical Method Validation. Rockville, MD: US Food and Drug Administration; 2001. Available at: http://www. fda.gov/downloads/Drugs/Guidances/ucm070107.pdf. Accessed February 1, 2014.
51. Fast DM, Kelley M, Viswanathan CT, et al. Workshop report and follow-up-AAPS workshop on current topics in GLP bioanalysis: assay repro-ducibility for incurred samples-implications of crystal city recommendations. AAPS J. 2009;11:238-241.
52. Yadav M, Shrivastav PS. Incurred sample reanalysis (ISR): a decisive tool in bioanalytical research. Bioanalysis. 2011;3:1007-1024.
53. Morris RG, Black AB, Lam E, et al. Clinical study of lamotrigine and valproic acid in patients with epilepsy: using a drug interaction to advantage? Ther Drug Monit. 2000;22:656-660.
54. Krasowski MD, McMillin GA. Advances in anti-epileptic drug testing. Clin Chim Acta. 2014;436C:224-236.
55. Annesley TM. Ion suppression in mass spectrometry. Clin Chem. 2003; 49:1041-1044.