title: Therapeutic drug monitoring for sirolimus in whole blood of organ transplants by high-performance liquid chromatography with ultraviolet detection.
abstract: We developed and validated an accurate, sensitive, precise and rapid HPLC method with UV detection for the determination of sirolimus in blood samples from renal, cardiac and hepatic transplants. This method overcomes most of the problems related to previously published assays using a narrow-bore column with base deactivated C18 reversed phase. Whole blood samples were purified by a combination of a precipitating blood matrix with zinc sulphate and a single step liquid-liquid extraction with acetone and 1-chlorobutane. Calibration curves (range 2.5-150 ng/ml), were linear with coefficients of correlation better than 0.996. The relative standard deviation was determined to be less than 8%. The present method has also been validated by a reference laboratory (St. George's Hospital Medical School, London, UK). More of 300 clinical samples have been analysed with this method.
authors.affiliation: Servicio de Farmacología Clínica, Clínica Universitaria de Navarra, 31080, C/Pio XII s/n. 31008 Pamplona (Navarra), Spain. macampaner@unav.es
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: Campanero
authors.forename: Ernesto
authors.initials: E
authors.lastname: Cardenas
authors.forename: Belén
authors.initials: B
authors.lastname: Sádaba
authors.forename: Emilio
authors.initials: E
authors.lastname: García-Quetglas
authors.forename: Maria Jose
authors.initials: MJ
authors.lastname: Muñoz-Juarez
authors.forename: Isabel
authors.initials: I
authors.lastname: Gil-Aldea
authors.forename: David
authors.initials: D
authors.lastname: Pazo
authors.forename: Jose Ramón
authors.initials: JR
authors.lastname: Azanza
authors.forename: Jesús
authors.initials: J
authors.lastname: Honorato
mesh_terms: D019540:Area Under Curve; D001711:Biotransformation; D002851:Chromatography, High Pressure Liquid; D016903:Drug Monitoring; D006207:Half-Life; D016027:Heart Transplantation; D006801:Humans; D007166:Immunosuppressive Agents / Q000097:blood* / Q000493:pharmacokinetics; D007202:Indicators and Reagents; D016377:Organ Transplantation; D012015:Reference Standards; D015203:Reproducibility of Results; D020123:Sirolimus / Q000097:blood* / Q000493:pharmacokinetics; D012996:Solutions; D013056:Spectrophotometry, Ultraviolet
chemical_list: D007166:Immunosuppressive Agents; D007202:Indicators and Reagents; D012996:Solutions; D020123:Sirolimus