Rapid and sensitive method for quantification of Lamotrigine in Human Plasma by Liquid Chromatography- Mass Spectrometry

Introduction: LCMS/MS is a reference method which can be applied to drugs with narrow therapeutic interval and it helps in better patient management. df LCMSMS was used as a method used in research labs but it is time now that clinical laboratories start using and applying in routine clinical practise. Therapeutic drug monitoring (TDM) of antiepileptic drugs is necessary to optimize patient's clinical outcome. Lamotrigine is approved for the treatment of partial seizures. There are different methods of testing for Lamotrigine. Conventional quantitative methods provide insufficient sensitivity, longer chromatographic run time and a labour intensive work-up procedure which nowadays are less favoured in industries to support clinical studies. Background: Steps of method development on LCMS/MS include Literature survey, Procurement of Analyte and Internal Standard, Materials and chemical, Preparation of Calibration Standards, Tuning of Analyte and Internal Standard, Selection of mobile phase and Column, Sample Preparation, analysis of chromatogram (peak) of Lamotrigine and internal standard. Material and Methods: Retrospective study of 1 year data--May 2015 to May 2016. Data was analysed age wise, gender wise and result value wise. Out of 136 samples received, 71% results were within normal range 76% males and 69% females had normal values. Clinicians were informed results for low and high values and accordingly dosage adjustments were done. Conclusion: A highly sensitive, fast and selective method for the detection and quantification of Lamotrigine in human plasma has been developed and validated by using LCMS/MS. A chromatography time of 3 min is now made possible to analyse more samples per day Keywords: LCMSMS, Lamotrigine.