Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR THE ESTIMATION OF LAMOTRIGINE IN HUMAN PLASMA

Ashok Kumar*, Maya Dutt Joshi, Akanksha Gupta, Sanjay Gurule, Rupesh Kumar, Rahul Kaushik, Nishant Chaudhary, Aditya Pundhir, Manisha Rastogi

ABSTRACT

A Simple, rapid, selective and sensitive liquid chromatographic mass spectrometry method was developed and validated for the determination of Lamotrigine from human plasma. The drug was extracted by ethyl acetate. Lamotrigine was measured in plasma using a validated method with mass spectrometer detector. Chromatographic peaks were separated on 4μm Chromolith, RP C-18 (504.6mm, 4μ) using 80:20 v/v Phosphate buffer pH 2.5, Acetonitrile asmobile phase at a flow rate of 0.500 ml/min. The chromatograms showed good resolution and no interference from plasma. The mean recovery from human plasma was found to be above 85%. The method was linear over the concentration range of 5 μg/ml to 1200 μg/ml with coefficient of correlation (r2) 0.9987. Both intraday and interday accuracy and precision data showed good reproducibility. This method was successfully applied to pharmacokinetics studies.

Keywords: Lamotrigine, Human plasma, LC/MS.