期刊
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
卷 31, 期 1, 页码 29-38出版社
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/S0731-7085(02)00599-X
关键词
cyproheptadine hydrochloride; cyproheptadine chloromethochloride; dichloromethane adduct; LC-MS; NMR; TLC
The British Pharmacopoeia (BP) monograph for cyproheptadine HCl tablets requires a 'Related substances' thin-layer chromatography (TLC) test. This test revealed an extraneous spot with an R-f of 0.1 in certain cyproheptadine HCl tablets that were under ambient retention conditions as well as those on stability programs. An investigation utilizing LC-MS, direct infusion MS, NMR, and organic synthesis has identified that the spot results from the N-oxide of cyproheptadine (a genuine degradate) and a co-eluting cyproheptadine-dichloromethane adduct, an artifact formed during the sample extraction step in which dichloromethane is used in the extracting solvent. (C) 2002 Elsevier Science B.V. All rights reserved.
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