RP-HPLC METHOD DEVELOPMENT & VALIDATION FOR THE ESTIMATION OF DEFERASIROX IN BULK & DOSAGE FORM

*Mohini Khare, Jyoti Sonawane, Shaikh Siddiqua, Abhay Kulkarni, Sambhaji Shelar and Sonali Suryawanshi

ABSTRACT

Objective: The present paper describes a simple, accurate, and precise reversed-phase high-performance liquid chromatography (HPLC) method for rapid and simultaneous quantification of Deferasirox in bulk and pharmaceutical dosage form. Methods: The chromatographic separation was achieved on C18 (250mmx4.6mm, 5μ id). Mobile phase contained a mixture of methanol: water in the ratio of 50:50 v/v, flow rate 1.0ml/min and ultraviolet detection at 247 nm. Results: The retention time of Deferasirox was 3.48min. The proposed method shows a good linearity in the concentration range of 10–60 μg/ml for Deferasirox under optimized conditions. Precision and recovery study results are in between 95.54 to102.28. Conclusion: This method is validated for different analytical performance parameters like linearity. Precision, accuracy, limit of detection, limit of quantification, robustness, and pharmacokinetic study were determined according to the International Conference of Harmonization (ICH) Q2B guidelines. All the parameters of validation were found in the acceptance range of ICH guidelines.

Keywords: Deferasirox, Methanol, Water, Method Validation.