Abstract

VALIDATED UV SPECTROSCOPIC METHOD FOR THE ESTIMATION OF LAMOTRIGINE IN BULK AND FORMULATION

M. Lohita*, P. Jaya Preethi, D. Naresh, K. Swetha, K. Saravana kumar,V. Amrutha

ABSTRACT

A simple, selective, accurate and precise UV method for analysis of Lamotrigine in tablet pharmaceutical dosage was developed and validated. The stock solution of 50g/ml was prepared and concentrations ranging from 2.5-25g/ml of Lamotrigine using methanol were prepared for linearity. Absorbances of these solutions were measured at 307.5nm. The linear regression analysis data for the linearity plot showed good linear relationship with correlation coefficient value, R2 = 0.998 in the concentration range 2.5-25g/ml with slope 0.03747 and intercept 0.01846. The method was validated according to the ICH guidelines for linearity, range, accuracy, precision, LOD, LOQ, robustness, specificity and selectivity for both bulk powder and pharmaceutical formulation. Lamotrigine was determined for its assay in tablet dosage form with 98.72%. The accuracy of the method was validated by recovery studies for 75,100,125 % levels and was found to be significant and under specification limits, with % recovery 98.5- 101.2 (within acceptable range 98- 102%). The LOD for 250ng/ml value is 0.002 and LOQ for 750μg/ml value is 0.025. The method was found to be robust.

Keywords: Lamotrigine, UV spectrophotometer, ICH guidelines.