Validation of a practical liquid chomatography with ultraviolet detection method for quantification of whole-blood everolimus in a clinical TDM laboratory

Therapeutic Drug Monitoring

Volumn 27, Issue 2, 2005, Pages 171-177

  Boudennaia, Tatiana Y ^a   Napoli, Kimberly L ^a  

^a UNIVERSITY OF TEXAS MEDICAL SCHOOL   (United States)

Author keywords

Everolimus; Liquid chromatography; TDM; Ultraviolet

Indexed keywords

32 DESMETHOXYRAPAMYCIN; ACETONITRILE; EVEROLIMUS; HEXANE; RAPAMYCIN; UNCLASSIFIED DRUG; WATER;

ACCURACY; ARTICLE; CALIBRATION; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG ISOLATION; DRUG MONITORING; DRUG STABILITY; ELUTION; FLOW RATE; LABORATORY TEST; PHASE SEPARATION; PRECIPITATION; PRIORITY JOURNAL; QUALITY CONTROL; REVERSED PHASE LIQUID CHROMATOGRAPHY; SENSITIVITY AND SPECIFICITY; STANDARD; ULTRAVIOLET RADIATION; VALIDATION PROCESS;

CHROMATOGRAPHY, LIQUID; DRUG MONITORING; GUIDELINE ADHERENCE; SIROLIMUS; SPECTROPHOTOMETRY, ULTRAVIOLET; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 16244395189     PISSN: 01634356     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.ftd.0000152681.13647.85     Document Type: Article

References (22)

1. Sedrani R, Cottens S, Kallen J, et al. Chemical modification of rapamycin: the discovery of SDZ RAD. Transplant Proc. 1998;30:2192-2194.
2. Schuurman HJ, Cottens S, Fuchs S, et al. SDZ RAD, a new rapamycin derivative: synergism with cyclosporine. Transplantation. 1997;64:32-35.
3. Dumont FJ. Everolimus. Curr Opin Investig Drugs. 2001;2:1220-1234.
4. Kovarik JM, Hartmann S, Figueiredo J, et al. Effect of food on everolimus absorption: quantification in healthy subjects and a confirmatory screening in patients with renal transplants. Pharmacotherapy. 2002;22:154-159.
5. Kovarik JM, Kalbag J, Figueiredo J, et al. Differential influence of two cyclosporine formulations on everolimus pharmacokinetics: a clinically relevant pharmacokinetic interaction. J Clin Pharmacol. 2002;42:95-99.
6. Kovarik JM, Sabia HD, Figueiredo J, et al. Influence of hepatic impairment on everolimus pharmacokinetics: implications for dose adjustment. Clin Pharmacol Ther. 2001;70:425-430.
7. Van Damme-Lombaerts R, Webb NA, Hoyer PF, et al. Single-dose pharmacokinetics and tolerability of everolimus in stable pediatric renal transplant patients. Pediatr Transplant. 2002;6:147-152.
8. Kovarik JM, Hsu CH, McMahon L, et al. Population pharmacokinetics of everolimus in de novo renal transplant patients: impact of ethnicity and comedications. Clin Pharmacol Ther. 2001;70:247-254.
9. Kovarik JM, Kaplan B, Tedesco Silva H, et al. Exposure-response relationships for everolimus in de novo kidney transplantation: defining a therapeutic range. Transplantation. 2002;73:920-925.
10. Vidal C, Kirchner GI, Wunsch G, et al. Automated simultaneous quantification of the immunosuppressants 40-O-(2-hydroxyethyl) rapamycin and cyclosporine in blood with electrospray-mass spectrometric detection. Clin Chem. 1998;44:275-282.
11. Segarra I, Brazelton TR, Guterman N, et al. Development of a high-performance liquid chromatographic-electrospray mass spectrometric assay for the specific and sensitive quantification of the novel immunosuppressive macrolide 40-O-(2-hydroxyethyl)rapamycin. J Chromatogr B Biomed Sci Appl. 1998;720:179-187.
12. Kirchner GI, Vidal C, Winkler M, et al. LC/ES1-MS allows simultaneous and specific quantification of SDZ RAD and cyclosporine, including groups of their metabolites in human blood. Ther Drug Monit. 1999;21:116-122.
13. Christians U, Jacobsen W, Serkova N, et al. Automated, fast and sensitive quantification of drugs in blood by liquid chromatography-mass spectrometry with on-line extraction: immunosuppressants. J Chromatogr B Biomed Sci Appl. 2000;748:41-53.
14. McMahon LM, Luo S, Hayes M, et al. High-throughput analysis of everolimus (RAD001) and cyclosporin A (CsA) in whole blood by liquid chromatography/mass spectrometry using a semi-automated 96-well solid-phase extraction system. Rapid Commun Mass Spectrom. 2000;14:1965-1971.
15. Brignol N, McMahon LM, Luo S, et al. High-throughput semi-automated 96-well liquid/liquid extraction and liquid chromatography/mass spectrometric analysis of everolimus (RAD 001) and cyclosporin a (CsA) in whole blood. Rapid Commun Mass Spectrom. 2001;15:898-907.
16. Deters M, Kirchner G, Resch K, et al. Simultaneous quantification of sirolimus, everolimus, tacrolimus and cyclosporine by liquid chromatography-mass spectrometry (LC-MS). Clin Chem Lab Med. 2002;40:285-292.
17. Streit F, Armstrong VW, Oellerich M. Rapid liquid chromatography-tandem mass spectrometry routine method for simultaneous determination of sirolimus, everolimus, tacrolimus, and cyclosporin A in whole blood. Clin Chem. 2002;48:955-958.
18. Salm P, Taylor PJ, Lynch SV, et al. Quantification and stability of everolimus (SDZ RAD) in human blood by high-performance liquid chromatography-electrospray tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2002;772:283-290.
19. Napoli KL, Kahan BD. Routine clinical monitoring of sirolimus (rapamycin) whole-blood concentrations by HPLC with ultraviolet detection. Clin Chem. 1996;42:1943-1948.
20. French DC, Saltzgueber M, Hicks DR, et al. HPLC assay with ultraviolet detection for therapeutic drug monitoring of sirolimus. Clin Chem. 2001;47:1316-1319.
21. Food and Drug Administration. Guidance for Industry. Bioanalytical Method Validation. Accessed October 6, 2003 at www.fda.gov/cder/guidance/4252fnl.pdf 2001.
22. Holt DW, Lee T, Jones K, et al. Validation of an assay for routine monitoring of sirolimus using HPLC with mass spectrometric detection. Clin Chem. 2000;46:1179-1183.