A rapid and simple assay for lamotrigine in serum/plasma by HPLC, and comparison with an immunoassay

Abstract

Monitoring serum/plasma concentrations of lamotrigine may be useful under certain circumstances. An HPLC column packed with strong cation-exchange (SCX)-modified microparticulate silica together with a 100% methanol eluent containing an ionic modifier permits direct injection of sample extracts. An HPLC-UV method developed using this principle for the measurement of serum/plasma lamotrigine is simple, sensitive and selective. The analysis time is less than 5 min. Intra- and inter-assay precision and accuracy meet acceptance criteria, and sample stability, and potential interferences from other compounds have been evaluated. There was good agreement with consensus mean results from external quality assessment samples (n = 32). Analysis of patient samples (n = 115) using the HPLC method and the Seradyn QMS® Lamotrigine immunoassay showed that the immunoassay over-estimated lamotrigine by 21% on average.

Development and validation of an improved HPLC-UV method for simultaneous determination of lamotrigine and oxcarbazepine and its active metabolite 10,11-dihydro-10-hydroxycarbazepine in human blood plasma and comparison with an UHPLC-MS/MS method

“…The IS normalized recovery (96.30 to 107.69% for LTG, 98.51 to 111.04% for MHD, and 95.04 to 108.75% for OXC at four QC levels) was similar compared with the values in many published studies (84.16 to 103.7% for LTG, 77.30 to 104.40% for MHD, and 79.30 to 96.93% for OXC) (Serralheiro et al, 2013;Kimiskidis et al, 2007;Begas et al, 2017;Alves et al, 2007;Contin et al, 2005). The freeze-thaw and longterm storing stabilities were similar to the published results (Serralheiro et al, 2013;Baldelli et al, 2015b;Morgan et al, 2011;Antonilli et al, 2011). Three analytes were stable at room temperature for 9 h, while in the literature, they were stable for 4 h (Serralheiro et al, 2013;Fortuna et al, 2010).…”

“…HPLC-UV was higher than UHPLC-MS/MS for LTG analysis with a mean value of 0.6 mg/L, which could be explained by the co-elution of endogenous impurities attributed to the well-known less specificity of UV detector (Zhang et al, 2019). Quantitative microsphere system LTG immunoassay was applied in the clinical practice and compared with HPLC-UV method in the previous studies (Westley & Morris, 2008;Baldelli et al, 2015a;Morgan et al, 2011). The results demonstrated a significant overestimation (6 to 21%) for the immunoassay which might be caused by the crossreaction of the antibody used in the assay with the N2glucuronide metabolite of LTG (Westley & Morris, 2008;Morgan et al, 2011).…”

“…Quantitative microsphere system LTG immunoassay was applied in the clinical practice and compared with HPLC-UV method in the previous studies (Westley & Morris, 2008;Baldelli et al, 2015a;Morgan et al, 2011). The results demonstrated a significant overestimation (6 to 21%) for the immunoassay which might be caused by the crossreaction of the antibody used in the assay with the N2glucuronide metabolite of LTG (Westley & Morris, 2008;Morgan et al, 2011). The mean bias and 95% LOA of MHD observed between the two methods were relatively high perhaps because of the small sample size.…”

An Updated Overview on Therapeutic Drug Monitoring of Recent Antiepileptic Drugs

“…TDM of lamotrigine may be further complicated by pharmacodynamic interactions as demonstrated for co-medication with carbamazepine [95]. Assay of lamotrigine based on HPLC [151, 152], turbidimetric immunoassay [153], GC–MS [154], and GC and densitometric methods [155] have been reported.…”

Avaliação de microtécnicas de extração para análise de lamotrigina em plasma de pacientes epilépticos por eletroforese capilar

“…É eficaz no tratamento de crises epilépticas generalizadas e focais, no tratamento adjunto da epilepsia refratária (PUCCI et al, 2005;KIM et al, 2015), pode ser empregada como estabilizador de humor em pacientes com transtorno bipolar (SARACINO et al, 2007;MORGAN et al, 2011;KIM et al, 2015;NIKOLAOU et al, 2015) e no tratamento da síndrome de Lennox-Gastaut (KIM et al, 2015;MOSHÉ et al, 2015). Além disso, estudos demonstraram que a LTG pode ser eficaz no tratamento a dependência de cocaína, álcool e inalantes (ZALEWSKA-KASZUBSKA et al, 2015).…”