STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF DEFERASIROX IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORMS

A simple, selective, precise and stability indicating RP-HPLC method for analysis of Deferasirox in bulk drug and pharmaceutical
dosage forms was developed and validated. The chromatographic conditions comprised of a reversed phase C18 column (hypersil
150mm×4.6, 5µm particle size), with a mobile phase composed of mixture of Methanol and Sodium Dihydrogenorthophosphate buffer
(i.e, prepared by diluting 7gms of Sodium Dihydrogen Orthophosphate dissolved in 500 ml of water and pH was adjusted to 7) in the
ratio of 30:70 v/v respectively. Flow rate was adjusted to 1.0ml/min. Detection was carried out at 215nm. The retention time of
Deferasirox was found to be 2.390 min. The linear regression analysis data for the calibration plots showed good linear relationship
within the concentration range 5-15µg/ml. The value of correlation coefficient was found to be 0.9995. The drug undergoes
degradation under thermal, acidic, basic, peroxide and robustness conditions. All the peaks of degraded products were resolved from
the active pharmaceutical ingredient with significantly different retention time. As the method could effectively separate the drug from
its degradation product, it can be employed as a stability indicating one.