Development and Validation of New RP-HPLC Method for the Determination of Dexrazoxane

A new sensitive, precise, rapid and linear RP-HPLC method was developed and validated for the determination of dexrazoxane in formulations and human serum samples. Good chromatographic separation of dexrazoxane was achieved by using Kromasil C(18) column. The system was operated at ambient temperature using a mobile phase consisting of methanol, 5% ortho phosphoric acid, 0.01M ammonium dihydrogen phosphate and tetrahydrofuran, pH 4.2 (10:40:30:20, v/v) isocratically at a flow rate of 1 ml/min. The method showed high sensitivity with good linearity (r(2)=0.9998) over the tested concentration range of 0.1 to 0.9 mg/ml. Detection was carried out at 272 nm and retention time was 7.005 min. The accuracy, formulation assay and percentage of RSD were 100.03, 97.48 and 0.03184, respectively with tailing factor (1.84). This method can be used for the routine quality control analysis.