VALIDATED RP-HPLC METHOD DEVELOPMENT FOR THE ESTIMATION OF DECITABINE & CEDAZURIDINE IN ITS COMBINEDVALIDATED RP-HPLC METHOD DEVELOPMENT FOR THE ESTIMATION OF DECITABINE & CEDAZURIDINE IN ITS COMBINED DOSAGE FORMS.

A new, simple, rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validation of Decitabine and Cedazuridine in its pure form as well as in combined marketed formulation. Chromatography was carried out on a Phenomenex Luna C18 (4.6mm×250mm) 5µm particle size column using a mixture of Methanol: Water (45:55% v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 240nm. The retention time of the Decitabine and Cedazuridine was found to be was 2.133, 3.692 ± 0.02min respectively. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The method produce linear responses in the concentration range of 20-60mg/ml of Decitabine and 10-30mg/ml of Cedazuridine. The inter-day and intra-day precisions were found to be within limits. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations. Keywords: Decitabine and Cedazuridine, RP-HPLC, Validation, Accuracy, Precision.