Abstract

DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR QUANTIFICATION OF LAMOTRIGINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Geetharam Yanamadala*, Sravya.J

ABSTRACT

A simple, precise, stability indicating RP-HPLC method was developed and validated for the assay determination of Lamotrigine in bulk drug and dosage form. LC separation was achieved isocratic mode on a Inertsil C8-3 (4.6x250) mm, 5 μm column using mobile phase containing KH2PO4 buffer (pH 2.5 ) :Methanol in the ratio 50: 50 at flow rate 1.5 ml/min. The detection wavelength was 270 nm and temperature was 25˚c. The retention time was 3.5 min and linearity was observed in the concentration range of 40-160 μg/ml with correlation coefficient of 0.999. The percentage relative standard deviation in accuracy and precision studies was found to be less than 2%. The method was successfully validated as per ICH guidelines. Lamotrigine undergoes degradation under acidic, basic, oxidation, dry heat and photolytic conditions, degradation impurities did not interfere with the retention time of Lamotrigine, and assay method is thus stability indicating.

Keywords: Lamotrigine, validation, HPLC, Stability indicating.