Stability Indicating Method Development and Validation for Determination of Daunorubicin and Cytarabine in Bulk and Pharmaceutical Dosage Form by RP-HPLC

Abstract

A Simple, Accurate and Precise method was developed for the simultaneous estimation of Daunorubicin and Cytarabine in bulk and pharmaceutical dosage form by RPHPLC technique. Chromatogram was run through standard Zorbax C18 (150mm x 4.6 mm, 5μ particle size). Mobile phase containing buffer 0.01N KH2PO4: Acetonitrile taken in the ratio of 60:40 was pumped through column at a flow rate of 1.0 ml/min. Buffer used in this method was 0.01N KH2PO4 buffer. Temperature was set to 30C. Optimized wavelength selected was 240.0 nm. Retention time of Cytarabine and Daunorubicin were found to be 2.325 min and 3.208 nm. % RSD of Daunorubicin and Cytarabine were found to be 0.6 and 0.6 respectively. %Recovery was obtained as 100.30% and 100.33% for Daunorubicin and Cytarabine respectively. LOD, LOQ values obtained from regression equation of Daunorubicin and Cytarabine were 0.09, 0.28 and 0.32, 0.97 respectively. The regression equation of Daunorubicin and Cytarabine is y=39589X+28710 and y=32928X+12457 respectively Retention times were decreased and that run was decreased, so the method was simple and economical that can be adopted in regular Quality control test in Industries.