Abstract

A simple, selective, linear, precise, and accurate RP-HPLC method was developed and validated for the Quantitation of Fingolimod Hydrochloride from bulk and formulations. Chromatographic separation was achieved isocratically on Zorbax Plus C 8 column (250×4.6 mm, 5μ particle size) using a mobile phase, Acetonitrile and Di-butyl ammonium phosphate buffer in the ratio of 45:55 v/v. The flow rate was 2.0 ml/min and effluent was detected at 198 and 100μl of sample was injected. Linearity was observed in the concentration range of 0.224 – 1.68 μg/ml. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The method developed can be used for the routine analysis of Fingolimod hydrochloride. BCS class of Fingolimod was determined by testing solubility, dissolution profile and lipophilicity by partition coefficient.