HPLC Analytical Method Development and Validation for Estimation of Cytarabine and Daunorubicin in API and Pharmaceutical Formulation

Abstract

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Cytarabine and Daunorubicin, in its pure form as well as in pharmaceutical dosage form. Chromatography was carried out on an Altima C18 (4.6mm x 150mm, 5µm) column using a mixture of ACN, Methanol and Phosphate buffer pH-4.6 (10:25:65 v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 265nm. The retention time of the Cytarabine and Daunorubicin was 2.088, 6.068±0.02 min respectively. The method produces linear responses in the concentration range of 10-50mg/ml of Cytarabine and 20-100mg/ml of Daunorubicin. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.