Analytical Method Development And Validation For Determination Of Azacitidine By High Performance Liquid Chromatography

Abstract

A New simple, accurate rapid and precise isocratic high performance liquid chromatographic (HPLC) method was developed and validated for the estimation AZACITIDINE from its bulk drug.  The HPLC method was developed Zorbax bonus RP, 250mm×4.6mm, 5µ column with mobile phase Ammonium acetate buffer and acetonitrile (75:25) in isocratic mode. Flow rate was 1.0ml/min, with injection volume 10µl, detection done by using PDA detector at 242nm. Retention time of azacitidine found to be 8.5min, the calibration was linear in concentration range of 15-225 µg/ml, with regression 0.999. The percentage recovery of v Azacitidine was found to be 99.1% - 100.75%. The LOD and LOQ of the azacitidine were found to be 0.0239 µg/ml and 0.0723µg/ml respectively. All the parameters validated according to ICH guide lines and found to be within the limits