Abstract
Aims: To develop and validate aUHPLC-MS/MS method for lamotrigine (LTG) analysis in human plasma and evaluate its agreement with ahomogenous enzyme immunoassay (HEIA). Materials &methods: The UHPLC-MS/MS method was developed and validated according to the USFDA/EMA guidelines. ABland-Altman plot was used to evaluate the agreement between UHPLC-MS/MS and HEIA. Results: Samples were pretreated with one-stepprotein precipitation and separated in 2.6min. The intra-and inter-day bias and imprecisions were -15.8to 15.0% and less than 11.17%, respectively. The recovery and matrix factor were 98.30to 111.97%. The mean overestimation of UHPLC-MS/MS compared with HEIA was 21.57%. Conclusion: A rapid, sensitiveand robust UHPLC-MS/MS method for plasma LTG analysis was developed and validatedand was a 21.57% overestimation compared with HEIA.
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