Abstract
A facile and rapid isocratic reverse phase high performance liquid chromatography assay method has been developed and validated for the determination of fingolimod in bulk and tablet dosage form. The column was equilibrated for at least 30 min and separation was achieved by using kromofil-ODS C18 (150 x 4.6 mm, particle size 5 μm). The column was maintained at ambient temperature (25°C). The mobile phase employed was methanol: water (60: 40 v/v). The eluent was monitored using UV detector at 220 nm. A volume of 10μL of standard and sample solutions was injected in to the HPLC. The flow rate was 1.0 mL/min. The retention times were 4.525 min for fingolimod. The method was found to be linear in the range of 25–150 μg/mL. The developed method was validated as per ICH guidelines. The developed method was found to be simple, precise, accurate, selective and sensitive.
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