title: Liquid chromatographic determination of amphotericin B in different pharmaceuticals.
abstract: Amphotericin B (AmB) is one of the most potent antifungal agents and the drug of choice in the treatment of serious fungal infections. A liquid chromatographic (LC) method was developed to determine AmB in pharmaceutical formulations for injection, tissue culture, cream, and lotion. pBondapak C18 reversed-phase column and a simple mobile phase consisting of acetonitrile-water-acetic acid (40 + 54 + 6, v/v) was used. The flow rate was 1.8 mL/min and the effluent was monitored at 405 nm. The developed LC method uses piroxicam as an internal standard and has a limit of detection of 10 ng/mL, a limit of quantitation of 30 ng/mL, and the assay is linear from 0.01 to 100 microg/mL. AmB and piroxicam elute with retention times of 12.4 and 4.0 min, respectively, and the resolution between AmB and piroxicam was 10.6. In comparison with the official United States Pharmacopeia microbial assay for AmB, this LC method is more rapid, selective, sensitive, and offers positive identification.
authors.affiliation: U.S. Food and Drug Administration, Department of Health and Human Services, Office of Regulatory Affairs, Jamaica, NY 11433, USA. llue@ora.fda.gov
authors.forename: Louis P
authors.initials: LP
authors.lastname: Lue
authors.forename: Susan T
authors.initials: ST
authors.lastname: Hadman
authors.forename: Ales
authors.initials: A
authors.lastname: Vancura
mesh_terms: D000666:Amphotericin B / Q000032:analysis* / Q000494:pharmacology; D000935:Antifungal Agents / Q000032:analysis* / Q000494:pharmacology; D001681:Biological Assay; D002853:Chromatography, Liquid; D046508:Culture Techniques; D004355:Drug Stability; D007202:Indicators and Reagents; D008826:Microbial Sensitivity Tests; D009824:Ointments; D010894:Piroxicam / Q000032:analysis; D012015:Reference Standards; D012441:Saccharomyces cerevisiae / Q000187:drug effects; D013056:Spectrophotometry, Ultraviolet
chemical_list: D000935:Antifungal Agents; D007202:Indicators and Reagents; D009824:Ointments; D010894:Piroxicam; D000666:Amphotericin B