Development and validation of a stability indicating HPLC assay method for determination of Lamotrigine in tablet formulation

The objective of the current study was to developed simple, precise and accurate isocratic reversed-phase stability indicating High Performance Liquid Chromatography (HPLC) assay method and validated for determination of lamotrigine in solid pharmaceutical dosage forms. Isocratic RP-HPLC separation was achieved on a Phenomenex Luna C8 (2) column (250 mm x 4.6 mm i.d., 5 μm particle size) using mobile phase of methanol- ammonium buffer (50:50, v/v) at a flow rate of 0.8 ml/min and the detection was carried out at 225 nm by using photo-diode array detector. The drug was subjected to oxidation, hydrolysis, photolysis and heat to apply stress condition. The method was validated for specificity, linearity, precision, accuracy, robustness and solution stability. The method was linear in the drug concentration range of 40-160 μg/ml with a correlation coefficient 0.9976. The precision Relative standard deviation (RSD) amongst six-sample preparation was 1.05 % for repeatability and the intermediate precision (RSD) amongst six-sample preparation was 0.85 %. The accuracy (recovery) was between 98.20 and 100.86 %. Degradation products produced as a result of stress studies did not interfere with detection of lamotrigine and the assay can thus be considered stability indicating

Author(s): Vijay R. Rama, Govind J. Kherb, Kapil L. Dubalb, Gaurang P. Pandyab and Hitendra S. Joshib

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