ZenToks Publication

CHAPTER 1

RP-HPLC Method Development and Validation for the estimation of Decitabine in Drug Dosage form

Abstract/Preface

A new, precise, rapid, accurate RP-HPLC method was developed for the estimation of Decitabine in pharmaceutical dosage form. After optimization the good chromatographic separation was achieved by Isocratic mode with a mixture of Ammonium Acetate buffer of pH 4.5: Acetonitrile (985:15) v/v as the mobile phase with Develosil RP Aqueous-AR-5 (150 x 4.6 mm, 5 μm), column as stationary phase at flow rate of 1.5 mL/min and detection wavelength of 244 nm. The Retention time of decitabine was found to be 3.786 min. The linearity of this method was found in the concentration range of 50-150 μg/mL. The correlation coefficient R2 value is found to be 0.998. The LOD for this method was found to be 0.0003 μg/mL. The LOQ for this method was found to be 0.0009 μg/mL. This method was found to be good percentage recovery about 99.77 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 analyte in the sample without interference from excipients of formulation. The method was extensively validated according to ICH guidelines for Linearity, Range, Accuracy, Precision, specificity and Robustness.