Isolation and characterization of degradation impurities in epirubicin hydrochloride injection.
The degradation of epirubicin hydrochloride aqueous formulation has been investigated during stability study. Some unknown degradation impurities were detected and out of these, three were characterized. These degradation impurities were isolated, enriched and were subjected to mass and NMR spectral studies. Based on the spectral data these were characterized as epirubicin dimer (impurity-1), 4-(4-amino-5-hydroxy-6-methyl-tetrahydro-pyran-2-yloxy)-2,5,12-trihydroxy-7-methoxy-6,11-dioxo-1,2,3,4,6,11-hexahydro-naphthacene-2-carboxylic acid hydroxymethyl ester (impurity-3) and 4-(4-amino-5-hydroxy-6-methyl-tetrahydro-pyran-2-yloxy)-2,5,12-trihydroxy-7-methoxy-6,11-dioxo-1,2,3,4,6,11-hexahydro-naphthacene-2-carboxylic acid (impurity-4). Structure elucidations of these degradation impurities are discussed in detail. Out of these degradation impurities, epirubicin dimer (impurity-1) has been previously identified while the other two impurity-3 and impurity-4 were previously unreported.
Analytical Laboratory-I, Dabur Research Foundation, 22 Site-IV, Sahibabad, Ghaziabad, Uttar Pradesh, India.
Dinesh
D
Kumar
Rajesh Singh
RS
Tomar
Santosh Kumar
SK
Deolia
Rajesh
R
Srivastava
Moloy
M
Mitra
Surendera
S
Tyagi
D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000737:chemistry* / Q000378:metabolism; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D015251:Epirubicin / Q000008:administration & dosage / Q000737:chemistry* / Q000378:metabolism; D007267:Injections; D019906:Nuclear Magnetic Resonance, Biomolecular; D053719:Tandem Mass Spectrometry
D000903:Antibiotics, Antineoplastic; D015251:Epirubicin