期刊
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
卷 46, 期 1, 页码 45-51出版社
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/j.jpba.2007.08.026
关键词
isometamidium; HPLC; LC-MS; counterfeit medicines; related substances
Isometamidium, a mixture of related substances of which 8-(3-m-amidinophenyl-2-triazeno)-3-amino-5-ethyl-6-phenylphenanthridinium chloride hydrochloride (M&B4180A) is the principal active component, is the only chemical agent available for prophylaxis of veterinary trypanosomiasis. A method for the simultaneous quantitation of the major constituents M&B4180A, 3-(3-m-amidinophenyl-2-triazeno)-8-amino-5-ethyl-6-phenylphenanthridinium chloride hydrochloride (M&B38897), 7-(m-amidinophenyldiazo)-3,8-diamino-5-ethyl-6-phenylphenanthridinium chloride hydrochloride (M&B4250) and 3,8-di(3-m-amidinophenyltriazeno)-5-ethyl-6-phenylphenanthridinium chloride dihydrochloride (M&B4596) is described. The related substances are resolved on a Gemini C18 column (150 mm x 4.6 mm, 5 mu m) using a mobile phase composed of a mixture of acetonitrile and 50 mM ammonium formate buffer pH 2.8 (25:75 v/v) at a flow rate of 1 ml/min with UV detection at 320 nm. The method is compatible with electrospray ionisation mass spectrometry and provides a tool for the control of substandard and counterfeit commercial preparations of isometamidium. (c) 2007 Elsevier B.V. All rights reserved.
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