RP-HPLC Method Development and Validation for Simultaneous Determination of Decitabine and Cedazuridine in Pure and Tablet Dosage Form

Abstract

A simple, rapid, accurate and precise isocratic reversed phase high performance liquid chromatographic method has been developed and validated for simultaneous estimation of Decitabine and Cedazuridine in tablet dosage form. The chromatographic separation was carried out on Zorbax C18 column (150 mm x 4.6 mm I.D., 5 μm particle size) with a mixture of 0.01N potassium dihydrogen phosphate buffer and acetonitrile in the ratio of 65:35% v/v as a mobile phase at a flow rate of 1.0 mL/min. UV detection was performed at 245 nm. The retention times were 2.263 minutes and 3.001 minutes for Decitabine and Cedazuridine respectively. Calibration plots were linear (r2=0.999 for both Decitabine and Cedazuridine respectively) over the concentration range of 8.75-52.5 μg/mL for Decitabine and 25-150 μg/mL for Cedazuridine. The method was validated for linearity, precision, accuracy, ruggedness and robustness. The proposed method was successfully used for simultaneous estimation of Decitabine and Cedazuridine in tablet dosage form. Validation studies revealed that the proposed method is specific, rapid, reliable and reproducible. The high % recovery and low % RSD confirms the suitability of the proposed method for routine quality control analysis of Decitabine and Cedazuridine in bulk and tablet dosage form.