Stability indicating HPLC-method for the determination of econazole nitrate in cream and lotion formulations.

A simple, fast HPLC-method for the determination of econazole nitrate in cream (Pevaryl, Pevisone) and lotion formulations (based on polyethylenic oleic glycerides and mono/di-stearic esters of ethylene- and polyethylene glycol) is described. The method is stability indicating as well as linear (range 5-15 mg econazole nitrate/g) and shows a good recovery (98.7-100.2%) and a good reproducibility (cv less than 1%, n = 10). The chromatographic separation is achieved on a RP-18 column using methanol/aqueous ammoniumcarbonate solution/tetrahydrofurane as the mobile phase. Quantification of the chromatograms is done by internal standard method using peak areas.