METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF IMPURITIES IN DEFERASIROX BY RP-HPLC TECHNIQUE

Abstract

A simple and isocratic reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated for determination of Deferasirox and its impurities. The method was validated as per International Conference on Harmonization (ICHQ2A (R1)) guidelines for system suitability, precision, linearity, specificity, solution stability, robustness and ruggedness, limit of detection and limit of quantitation. Deferasirox was analyzed by using Inertsil ODS-3V (150 mm X 4.6 mm, 5 μm) at 35°C column temperature, with isocratic elution. The analysis was performed at a wavelength of 245 nm using dual λ absorbance detector. Efficient UV detection at 245 nm enabled determination of Deferasirox without any interference of impurities Salicylic acid & Salicylamide.  The retention time (RT) for Deferasirox was around 8.7 min. The impurities of Deferasirox are key starting materials. These impurities act as potential impurities. Thus identifying these impurities at low level is crucial. The calibration curves were linear over acceptable concentration range. The method developed was unique in determining the impurities even at low levels than that of specifications. The developed method was successfully applied to estimate the amount of Deferasirox.