HPTLC AND HPLC DETERMINATION OF ISOMETAMIDIUM IN THE PRESENCE OF ITS MANUFACTURING AND DEGRADATION IMPURITIES

The determination of the phenanthridine trypanocide, isometamidium chl oride hydrochloride (ISM), in the presence of four process-related and degradation impurities, by RP-HPLC using a Licrospher-60 RP-select B column with a mobile phase composition of acetonitrile/KH2PO4 (pH 3.0, 20 mM) (25:75 v/v) with UV detection at 320 nm, is described. The met hod is selective, reproducible and precise with a limit of detection o f 45 ng ml(-1) for ISM. A HPTLC system (Kieselgel 60 F254, pyridine/ac etonitrile/butanol/formic acid. 6.6.4.1, v/v), with UV densitometric e valuation at 320 nm, suitable for the separation of ISM and the relate d substances is reported. (C) 1998 Elsevier Science B.V. All rights re served.