Pages: 1206-1218
Date of Publication: 01-Dec-2013
DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR QUANTIFICATION OF FINGOLIMOD IN BULK AND PHARMACEUTICAL DOSAGE FORM
Author: PAWANJEET.J.CHHABDA*, M. BALAJI, SRINIVASARAO.V
Category: Pharmaceutical Sciences
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Abstract: A simple, precise, stability indicating RP-HPLC method was developed and validated for the assay determination of Fingolimod Hydrochloride in bulk drug and dosage form. LC separation was achieved gradient mode on a XBridge C18 (4.6x150) mm, 5 µm column using mobile phase containing solution A (0.1% perchloric acid) solution B( acetonitrile) at flow rate 0.8 ml/min. The detection wavelength was 220 nm and temperature was 40˚c. The retention time was 9.30 min and linearity was observed in the concentration range of 20-150 µg/ml with correlation coefficient of 0.9999. The percentage relative standard deviation in accuracy and precision studies was found to be less than 2%. The method was successfully validated as per ICH guidelines. Fingolimod undergoes degradation under acidic, basic, oxidation, dry heat and photolytic conditions, degradation impurities did not interfere with the retention time of fingolimod, and assay method is thus stability indicating.
Keywords: Fingolimod, validation, HPLC, Stability indicating
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