title: Simple and sensitive HPLC method for determination of amrubicin and amrubicinol in human plasma: application to a clinical pharmacokinetic study.
abstract: A simple and sensitive high-performance liquid chromatographic (HPLC) method was developed for determination of amrubicin and its metabolite amrubicinol in human plasma. After protein precipitation with methanol without evaporation procedure, large volume samples were injected and separated by two monolithic columns with a guard column. The mobile phase consisted of tetrahydrofuran-dioxane-water (containing 2.3 mM acetic acid and 4 mM sodium 1-octanesulfonate; 2:6:15, v/v/v). Wavelengths of fluorescence detection were set at 480 nm for excitation and 550 nm for detection. Under these conditions, linearity was confirmed in the 2.5-5000 ng/mL concentration range of both compounds. The intra- and inter-day precision and intra- and inter-day accuracy for both compounds were less than 10%. The method was successfully applied to a clinical pharmacokinetic study of amrubicin and amrubicinol in cancer patients.
authors.affiliation: National Cancer Center Hospital, Chuo-ku, Tokyo, Japan. reando@ncc.go.jp
authors.forename: Reiko
authors.initials: R
authors.lastname: Ando
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Makino
authors.forename: Tomohide
authors.initials: T
authors.lastname: Tamura
authors.forename: Noboru
authors.initials: N
authors.lastname: Yamamoto
authors.forename: Rena
authors.initials: R
authors.lastname: Nishigaki
authors.forename: Takehiro
authors.initials: T
authors.lastname: Kimura
authors.forename: Nobuaki
authors.initials: N
authors.lastname: Yokote
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Yamamoto
mesh_terms: D018943:Anthracyclines / Q000097:blood*; D000970:Antineoplastic Agents / Q000097:blood*; D002851:Chromatography, High Pressure Liquid / Q000191:economics / Q000379:methods*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy; D011446:Prospective Studies; D012680:Sensitivity and Specificity
chemical_list: D018943:Anthracyclines; D000970:Antineoplastic Agents; C116173:amrubicinol; C055866:amrubicin