Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DAUNORUBICIN AND CYTARANINE IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Mohana Sundaram RE* and Nanda Kumar KV

ABSTRACT

A simple, Accurate, precise method was developed for the simultaneous estimation of the Daunorubicin and Cytarabine in Tablet dosage form. Chromatogram was run through Std Kromosil 250 x 4.6 mm, 5. Mobile phase containing Buffer 0.1% OPA: Acetonitrile taken in the ratio 65:35 was pumped through column at a flow rate of 1.0 ml/min. Buffer used in this method was 0.1% OPA buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 240.0 nm. Retention time of Daunorubicin and Cytarabine were found to 2.729 min and 2.211. %RSD of the Daunorubicin and Cytarabine were and found to be 0.7 and 0.8 respectively. %Recovery was obtained as 99.99% and 99.54% for Daunorubicin and Cytarabine respectively. LOD, LOQ values obtained from regression equations of Daunorubicin and Cytarabine were 0.98, 2.96 and 1.03, 3.12 respectively. Regression equation of Daunorubicin is y = 73448.x+38469, y = 69369x+25775 of Cytarabine. 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.

Keywords: Daunorubicin, Cytarabine, RP-HPLC.