Development and Validation of Analytical Procedure using Core Shell Technology for Quantification of Lamotrigine in Pharmaceutical Product

This study describes the validation of an analytical process for the assay and identification of Lamotrigine in pharmaceutical product (orally disintegrating tablets).Key characteristics, such as linearity, robustness, stability of the analyte, specificity, accuracy, precision and intermediate precision, were used to verify the method.It was also determined that the method was equivalent to High-Performance Liquid Chromatography (HPLC).It was discovered that the analytical technique was stable for both standard and sample solutions, resilient under minor method modifications, linear over a wide concentration range, specific, exact, and accurate.The suitability of the UPLC (Ultra-Performance Liquid Chromatography) method for routine quality control testing of Lamotrigine formulations was confirmed by its equivalency to the current HPLC approach.Since core-shell column technology offers quick, repeatable and economical outcomes; thus this method can be used for routine quality control analysis of Lamotrigine.