RP-HPLC Method Development and Validation of Lamotrigine
By Pavan Kumar Puvvada, Vedi Gounder Murugan, S. Vimal Kumar, Pavan Kumar Padarthi
A simple, rapid and precise method was developed for the quantitative determination of lamotrigine in tablets. The method was based on RP-HPLC. Chromatographic separation was performed on a Supelco C18 (25cm X 4.6mm and i.d., 5µm) column using a mobile phase of methanol and 0.05 M potassium dihydrogen orthophosphate (65: 35v/v) adjusted the pH 4.5 with dilute orthophosphoric acid. The following system conditions were maintained throughout development and validation i.e., flow rate 1ml/min, column was maintained at room temperature and the detected by a UV-wave length at 270 nm. The lamotrigine was well resolved on the stationary phase and the retention time was 3.7 minute. The method was validated and shown to be linear for lamotrigine in 20-100 µg /ml. the correlation coefficient for lamotrigine is 0.9998 respectively. The method was validated for Precision, Accuracy, LOD and LOQ were determined to be 15ng/ml and 5 ng/ml respectively.
Keywords : Lamotrigine, RP-HPLC, Method development and validation.