Abstract
The reverse phase high performance liquid chromatographic method has been developed for the estimation of Deferasirox in bulk and in tablet dosage form. Further optimized HPLC method was validated as per the current ICH guidelines. The experiment was conducted on a Inertsil ODS-3V C18, 150mm length, 4.6mm ID, and 5µm particle size column using the chromatographic separation was done with 60:40 v/v ratio of Acetonitrile and Buffer (0.05% Orthophosphoric Acid) as the mobile phase at a flow rate of 1.5mL min-1, and detection of component was made at 250nm. The HPLC method was accurate, with linearity ranging from 10.8 to 162µg/mL of Deferasirox, the correlation coeffient >0.999. The method was exposed to a high accuracy of more than 97%. The results disclose the successful applicability of the current process for the estimation of Deferasirox from its drug substance and marketed formulation, which can be consciously inferred to assess the other formulation systems. The developed method was validated in terms of linearity, accuracy, precision, LOD, LOQ, robustness & ruggedness. The proposed method can be helpful in Quality control laboratories for the determination of Deferasirox in the pharmaceutical dosage form.
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