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  • Chem Sci Trans., 2014, 3(3),  pp 1067-1077  

    DOI:10.7598/cst2014.685

    Research Article

    Identification, Isolation and Characterization of Unknown Impurity in Daunorubicin Hydrochloride

  • AJAY SINGH RAWAT*, VITTHAL BUCHUDE, KAMLESH CHAUHAN, DIVYESH PATEL, RITESH PATEL, CHANDRAKANT BELWAL and ANAND VARDHAN
  • Sterling Biotech Limited, Jambusar State Highway, Village Masar 391421, Taluka, Padra, Distt: Vadodara Gujarat India
  • 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-5,12-dione also known as 13-deoxy-daunorubicin.

    Keywords

    Daunorubicin, Unknown impurity, Chromatography, Preparative HPLC, Lyophilization, NMR, LC-MS, LC/MS/MS

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