STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF DAUNORUBICIN AND CYTARABINE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY

An economical UPLC method was developed for the simultaneous estimation of the Daunorubicin and Cytarabine in vial dosage form. In present study, the Chromatogram was run through X-Bridge C18 (100 x 2.1 mm, 1.6 mu m) column with mobile phase containing Buffer 0.01N KH2PO4: Acetonitrile taken in the ratio 50:50, was pumped at a flow rate of 0.3 ml/min. Buffer used in this method was 0.01N KH2PO4 (3.5 pH) and buffer pH was adjusted with 0.1% OPA. Optimized wavelength selected was 240.0 nm. Retention time of Daunorubicin and Cytarabine were found to be 0.958 min and 1.510 min. % RSD of the Daunorubicin and Cytarabine were found to be 0.8 and 0.6 respectively. % Recovery was obtained as 99.37 % and 100.10 % for Daunorubicin and Cytarabine respectively. LOD, LOQ values obtained from regression equations of Daunorubicin and Cytarabine were 0.14, 0.41 and 0.33, 1.00 respectively. Linearity equations were obtained for Daunorubicin was y = 2177.2x + 718.38 and Cytarabine was y = 4896.8x + 2531.1 respectively. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.