Development and validation of an improved HPLC method for the control of potentially counterfeit isometamidium products.

Abstract

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 microm) 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.

• Authors: G J Schad, A Allanson, S P Mackay, A Cannavan, J N A Tettey
• Journal: Journal of pharmaceutical and biomedical analysis (J Pharm Biomed Anal) Vol. 46 Issue 1 Pg. 45-51 (Jan 07 2008) ISSN: 0731-7085 [Print] England
• PMID: 17931814 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Validation Study)

Chemical References

• Azo Compounds
• Phenanthridines
• Trypanocidal Agents
• Veterinary Drugs
• isometamidium chloride
• Ethidium

Topics

• Animals
• Azo Compounds (analysis, chemistry)
• Chromatography, High Pressure Liquid (methods)
• Drug Contamination (prevention & control)
• Ethidium (analogs & derivatives, analysis, chemistry)
• International Cooperation
• Mass Spectrometry (methods)
• Molecular Structure
• Phenanthridines (analysis, chemistry, standards)
• Regression Analysis
• Reproducibility of Results
• Spectrometry, Mass, Electrospray Ionization (methods)
• Trypanocidal Agents (analysis, chemistry)
• Veterinary Drugs (analysis, chemistry)