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Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF DEFERASIROX IN BULK AND PHARMACEUTICAL DOSAGE FORM

Sagar Sunil Sontakke*, Prof. Afaque Raza Mehboob Ansari, Raviraj N. Jalkote, Kaveri C. Dulange, Akash A. Patil and Neha R. Gate

ABSTRACT

A simple, precise, accurate, economical and reliable UV spectrophotometric method has been developed for the estimation of Deferasirox in bulk and its tablet dosage form. The drug shows maximum absorption (λmax) at 260 nm in ethenol and obeys Beer’s law in the concentration range of 2-10 μg/ml with correlation coefficient (R2=0.999). The accuracy was found to be 98.3-100.09%. Limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.031 μg/ml and 0.95 μg/ml respectively. The relative standard deviation was found to be <2.0% in all cases. The proposed spectrophotometric method was validated as per ICH Q2 (R1) guidelines. Statistical analysis proved that the method is repeatable and specific for the determination of the said drug. The proposed method can be used for the reliable quantification of Deferasirox in bulk form and routine analysis of pharmaceutical formulations.

Keywords: Deferasirox, UV Spectrophotometer, Method Validation.


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