Abstract
Author(s): Bodduluri Anil Kumar1*and Pankaj Kumar Sharma2
The purpose of the investigation was to develop a new RP-HPLC method fortheestimationof Fingolimod inpharmaceuticaldosageform. Chromatography wascarriedout onan ODS column(4.6x250mm,5μparticlesize)withaisocratic mobilephase composed of Phosphate buffer and acetonitrile (40:60v/v) ataflowrate of 1.0mL/min. The column temperaturewas maintained at30°C and the detection was carriedoutusingaPDAdetectorat260 nm.Validation parameterssuchas system suitability, linearity,precision,accuracy,specificity, limit of detection, limit of quantification, stabilityof sample and standard stock solutions androbustnesswere studiedas reportedintheInternationalConferenceonHarmonization guidelines. The retentiontimeforFingolimod was2.9min.Therelative standarddeviation for assay oftabletsw a s f o un d t o be less than2%.The methodwasfast,accurate, preciseandsensitivehenceitcanbe employedfor routine quality control ofFingolimodtabletsinquality control laboratories and pharmaceutical industries