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Title Development and validation of rp-hplc method for the estimation of fingolimod in bulk and tablet dosage form
Authors J. Raghuram and N. Appalaraju
Description A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of Fingolimod in tablet dosage form.ZobraxEclipseXDB-C18, 150x4.6 mm 5 μm partical size, with mobile phase consisting of water: acetonitrile in the ratio of 60:40 v/v was used. The flow rate was 0.8 ml/min and the effluents were monitored at 215 nm. The retention time& Recovery time was 20.0min&3.273. The detector response was linear in the concentration of 60-360 mcg/ml. The respective linear regression equation being Y= 41219.363x+65555.8. The limit of detection and limit of quantification was 0.15mcg and 0.45mcg/ml respectively. The percentage assay of Fingolimod was 99.72 %. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Fingolimod in bulk drug and in its pharmaceutical dosage form.