Quality evaluation by capillary electrophoresis of amphotericin B injection after filtration through various membrane filters

The determination of amphotericin B, an antifungal agent, was developed using micellar electrokinetic capillary chromatography (MEKC) with a diode array detector. Repeatability and intermediate precision of MEKC analysis were acceptable. A high correlation was found between amphotericin B levels in pharmaceutical solutions obtained by MEKC and those by high‐performance liquid chromatography (HPLC) (r = 0.994). This MEKC method is therefore useful for the determination of amphotericin B. The concentration of amphotericin B did not significantly change after filtration through polyethersulfone (PES, 0.2 μm) and polyvinylidene difluoride (PVDF, 0.45 μm) membrane filters. When the Fungizone injection was filtered through PES (0.2 μm) and added to 5% dextrose for injection (500 mL), particulate matters larger than 10 μm decreased by 64% to a level under the standard defined by United States Pharmacopoeia (USP XXIII). PVDF filtration (0.45 μm) did not have this effect. Our results suggest that filtration of Fungizone injection through PES (0.2 μm) membrane filters is recommended for the preparation of intravenous amphotericin B fluid.