Abstract

NEWER ANALYTICAL VALIDATION OF LACOSAMIDE IN BULK AND THEIR TABLET DOSAGE FORM BY RP-UPLC

R. Valarmathi*, R. Senthamarai, S. Akilandeswari, S. Farisha Banu, R. Saratha, V. Revathi

ABSTRACT

A new sample, precise, accurate, sensitive, less time consuming isocratic Reverse Phase Ultra Performance Liquid Chromatography (RP-UPLC) method was developed and validated for the determination of Lacosamide (LCM) in their tablet dosage form. This method employs, Thermo Scientific Hypersil ODS C-18 column (50x 2.1 mm, particle size of 1.9μ) and flow rate 1mL/min with load of 10 μl. Methanol, Acetonitrile, Phosphate buffer (52 : 40 : 8 % v/v) composition was used as a mobile phase. PH 3 adjusted with Orthophosphoric acid. The detection was carried out at 257 nm for Lacosamide was found to be 1.5 minutes. Linearity range for Lacosamide was 404-604 μg/mL. Percent recovery study of Lacosamide was performed at three different levels. This newly developed method was successfully utilized for the routine analysis of LCM & tablet forms. This method was validated for accuracy, precision, linearity, system suitability parameters as per ICH guidelines.

Keywords: RP-UPLC, lacosamide, validation, tablet formulation.