Development of stability indicating RP-HPLC method for the estimation ofFingolimod in its bulk dosages form as per ICH guideline

An accurate, precise, rapid & economical RP-HPLC method was developed & validated for the estimation of Fingolimod in pharmaceutical dosage forms, using UV detector. Elution was carried out using a mobile phase consisting of Buffer : Water (60 : 40) and flow rate was set on 1.2 ml / min at 319 nm wave length, retention time for Fingolimod was found to be 3.329 min. The method was found to be linear within the range of 40-120 μg/ml. In the linearity study, regression equation and correlation coefficient was found to be y=14744x and 0.999 respectively. This method was Rugged and Robust in different testing criteria, LOD and LOQ was found to be 0.005 μg / ml & 0.17 μg / ml respectively. Accuracy study was done in 3 different concentration level i.e 50, 100, 150% & % recovery of the method was found to be 99.7%, 99.8%, 99.9% respectively in 3 different levels & mean recovery was 99.8 %, so method was accurate. Results of all validation parameter were within the limits as per ICH guideline.