Abstract
Deferasirox belongs to the class antidote, which is not official in any pharmacopoeia. But only a few reported studies were availableemploying RP-HPLC technique. To validate the analytical process, we chose bulk powder and tablets of different intensity deferasirox tablets.The objective of the research or analysis is to develop a sensitive reverse phase chromatography method and validate quantitative perseverance of deferasirox in bulk and marketed formulation. A Simple, precise, accurate, economical and reliable UVspectrometric method has been developed toestimate deferasirox bulk and its tablet dosage form. The method was validated as per the international conference on harmonization (ICHQ2AR1) the validated dosage type was tested for device suitability, precision, linearity, specificity, robustness, and ruggedness.Statistical analysis proved that the method is repeatable and specific for the determination of the said drug. The established procedure or technique was done using Inertsil ODS 3V (C18 250mm X 4.6mm, 5µm) column oven temperature 40°C and sample temperature is 8°C with a flow rate of 1.5mL/min. By using HPLC waters PU-2487 pump and photodiode array detector at 245nm. The separation was carried out using a mobile phase consisting of amixture of sodium di hydrogen phosphate monohydrate buffer (pH3.0) and acetonitrile in the ratio of 45:55. The retention time of Deferasirox peak was considered to be about 7.5 min and the total run time was found to be 20 minutes.The calibration plot gave linear relationship over the concentration range of 6.28- 811.480 µg/ml The average percent recovery was proved to be 96.1,97.6&103.The correlation coefficient was found to be 0.999. The relative standard deviation (R.S.D) was found <2.0% for the UV-spectroscopic RP-HPLC method. The percent assessment of the drug was around 100% indicating the accuracy of the procedure. The suggested techniques were further confirmed and employed for the testing of the drug in tablet preparation.
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