Therapeutic drug monitoring for sirolimus in whole blood of organ transplants by high-performance liquid chromatography with ultraviolet detection.
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.
Campanero
Miguel Angel
MA
Servicio de Farmacología Clínica, Clínica Universitaria de Navarra, 31080, C/Pio XII s/n. 31008 Pamplona (Navarra), Spain. macampaner@unav.es
Cardenas
Ernesto
E
Sádaba
Belén
B
García-Quetglas
Emilio
E
Muñoz-Juarez
Maria Jose
MJ
Gil-Aldea
Isabel
I
Pazo
David
D
Azanza
Jose Ramón
JR
Honorato
Jesús
J
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
D007166:Immunosuppressive Agents; D007202:Indicators and Reagents; D012996:Solutions; D020123:Sirolimus