Validated rp-hplc method development for the simutaneous estimation of decitabine and cedazuridine in its combined dosage forms

Abstract

A new, simple, precise, accurate and reproducible RP-HPLC method for Simultaneous estimation of Decitabine and Cedazuridine in bulk and pharmaceutical formulations. Separation of Decitabine and Cedazuridine was successfully achieved on a Phenomenex Luna C18 (4.6×250mm, 5µm) particle size or equivalent in an isocratic mode utilizing Acetonitrile: Phosphate Buffer (pH-4.6) (45:55 v/v) at a flow rate of 1.0mL/min and elutes was monitored at 245nm, with a retention time of 2.102 and 3.537 minutes for Decitabine and Cedazuridine respectively. The method was validated and the response was found to be linear in the drug concentration range of 6µg/mL to 14µg/mL for Decitabine and 18µg/mL to 42µg/mL for Cedazuridine. The values of the slope and the correlation coefficient were found to be 77824 and 0.999 for Decitabine and 10515 and 0.999 for Cedazuridine respectively. The LOD and LOQ for Cedazuridine were found to be 0.8 µg/mL and 2.4µg/mL respectively. This method was found to be good percentage recovery for Decitabine and Cedazuridine were found to be 100.351 and 100.93 respectively indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analytes in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Range, Accuracy, Precision, Specificity and Robustness.