15. Validated HPLC-UV method for simultaneous estimation of Deferasirox and its impurities

A reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the assay and process and degradation related impurities of Deferasirox. The method involves quaternary gradient pumps and variable wavelength UV detector. Chromatographic conditions include a 20 L injection volume, an Xterra RP-18 (150 X 4.6mm, 5 m) column (column temperature: 25°C), flow rate of 1.0 mL/min and detection at 250 nm. The separation of drug from its impurities was achieved by a gradient elution method, using the mobile phase composed of solution A (water adjusted to pH 2.5 with perchloric acid) and solution B (methanol). The retention times of Deferasirox, impurity A and impurity B are 37.7, 43.7 and 49.3 min, respectively. The method has been validated both for assay and impurity profiling as per ICH guideline. The method has been found to be sensitive, accurate, precise, and reproducible and a robust one for the regular quality control of Deferasirox drug substance. The same can also be used in the stability study of Deferasirox.