Identification, Isolation and Characterization of Unknown Impurity in Daunorubicin Hydrochloride

Abstract

An unknown impurity in the bulk drug daunorubicin hydrochloride observed at 1.79 RRT was detected by the means of reverse phase isocratic High performance liquid chromatography (HPLC). This impurity was isolated, enriched and was subjected to mass and NMR spectral studies. Based on the spectral data the impurity was identified as (8S,10S)-8-ethyl-10-[(2S,4S,5S,6S)-4-amino-5-hydroxy-6-methyl-oxan-2-yl]oxy-6,8,11-trihydroxy-1-methoxy-9,10-dihydro-7H-tetracene-5,12dione also known as 13-deoxy-daunorubicin.