Formulation of immediate release lamotrigine tablets and bioequivalence study
ABSTRACT:
Lamotrigine tablets were compressed directly by means of
Avicel PH102, sodium starch glycolate, magnesium stearate, Aerosil 200 and
PVPK25. A rapid, sensitive and simple high-performance liquid chromatographic
(HPLC) method for the determination of lamotrigine in plasma is described. The
drug was extracted from one mL of each rabbits plasma sample was transferred
into a 15 mL tube fitted with a polyethylene cap 1 mL acetonitrile were added
to the sample. The supernatant was injected into the HPLC system. The drug and
the internal standard (carbamazepine) were eluted from C18 Zorbax ODS(4.6 x
250mm, USA) column at ambient temperature with a mobile phase consisting of
acetonitrile and 20mM potassium dihydrogen phosphate buffer (35:65,v/v) and
adjusted to (pH7) using 1NNaOH, at a flow rate of 1.5 ml min-1 and the detector
was monitored at 210 nm. Quantitation was achieved by measurement of the
peak-area ratio of the drug to the internal standard and the lower limit of
detection for lamotrigine in plasma was 0.491 µg ml-1. The intraday precision
ranged from 0.801-7.692 % coefficient of variation (CV) and accuracy ranged
from 0.048-4.9(relative error%) for samples. The relative recoveries of
lamotrigine ranged from from 95.10 to 101.89%. The method was applied in
studying the pharmacokinetics of lamotrigine administered orally to rabbits.
This reliable micro-method would have application in pharmacokinetic studies of
lamotrigine. The relative percentage bioavailability of prepared lamotrigine
tablets with respect to the commercially available Lamictal® tablets was
134.68%.
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