Isolation and identification of a new impurity in mitoxantrone hydrochloride.
An unknown impurity in mitoxantrone hydrochloride bulk drug was detected by HPLC at levels around 0.5%. This impurity was isolated from a sample of crude mitoxantrone using preparative HPLC and was characterized as 1,4-dihydroxy-5-2-2-hydroxyethyl-amino-ethyl-amino-8-2-bis 2-hydroxyethyl-amino-ethyl-amino-9,10-anthracenedione based on its spectral data (NMR, IR and MS). The origin and structural elucidation of this impurity are discussed in the paper.
Haiyan
Ling
L
Sichuan University, West China School of Pharmacy Department, 610041 Chengdu, China. rbchao@scu.edu.cn
D000880:Anthraquinones / Q000032:analysis / Q000737:chemistry; D000970:Antineoplastic Agents / Q000032:analysis* / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D009682:Magnetic Resonance Spectroscopy; D013058:Mass Spectrometry; D008942:Mitoxantrone / Q000032:analysis* / Q000737:chemistry; D013055:Spectrophotometry, Infrared
C543444:1,4-dihydroxy-5-2-2-hydroxyethyl-amino-ethyl-amino-8-2-bis 2-hydroxyethyl-amino-ethyl-amino-9,10-anthracenedione; D000880:Anthraquinones; D000970:Antineoplastic Agents; D008942:Mitoxantrone