Simultaneous Estimation of Decitabine and Cedazuridine in Tablet Dosage Form by RP – HPLC Method

Abstract

A simple, rapid reversed-phase high performance liquid chromatographic method has been developed and validated for estimation of Decitabine and Cedazuridine in tablet dosage form. The estimation was carried out on Phenomenex – Luna C18 column (25cm x 4.60 mm, particle size 5µm) column with a mixture of 10mM phosphate buffer (PH 6.8): Acetonitrile; 40: 60 (v/v) as mobile phase. UV detection was performed at 260 nm. The method was validated for linearity, accuracy, precision, specificity and sensitivity as per ICH norms. The developed and validated method was successfully used for the quantitative analysis of commercially available dosage form. The retention time was 1.53 and 1.47 min. for Decitabine and cedazuridine respectively and total run time was 10 min. at a flow rate of 1.0 mL/min. The calibration curve was linear over the concentration range of 40-240 µg/mL for Decitabine and 60-360µg/mL for cedazuridine disoproxil fumarate. The LOD and LOQ values were found to be 1.54 and 4.54µg/mL for Decitabine and 4.6 and 13.65µg/mL for cedazuridine respectively. The high percentage of recovery and low percentage coefficient of variance confirm the suitability of the method for the simultaneous estimation of Decitabine and cedazuridinein tablet dosage form.