Stability-Indicating Reverse-Phase High-Performance Liquid Chromatographic Method Development and Validation of Lamotrigine in Bulk and Pharmaceutical Dosage Form

Abstract

In the current study, analytical method has been validated by system suitability parameters, linearity, accuracy and percent recovery, precision, ruggedness, robustness, limit of detection, and limit of quantification. The present study of lamotrigine was achieved using Cosmosil C18 (250 nm×4.6 ID, particle size: 5 Micron) Column with mobile phase methanol: water (60:40) pH: 3 at a flow rate 0.8 ml/min with UV detection at 308 nm. The retention time for lamotrigine was found to be 4.979 min. In linearity, the correlation coefficient (R2) for lamotrigine was found to be 0.999, slope is 39,801, and intercept was found to be 51,862 which are well within the acceptance criteria. The mean percent recovery for lamotrigine at three different levels for 50%, 100%, and 150% was found to be 99.28%, 99.30%, and 100.40%. The % RSD should not more than 2%. In precision study, interday (RSD is 0.41%) and intraday (RSD is 0.26%) are found. Forced degradation experiments were carried out by exposing standard form of lamotrigine for acid-base, oxidative, photolytic, and thermal stress conditions. Hence, the developed method is accurate, precise, repeatable, and reproducible and can be used for routine analysis of lamotrigine.