EVALUATION OF RAPAMYCIN STABILITY IN WHOLE BLOOD BY HPLC WITH ULTRAVIOLET DETECTION.
B. KISS1,*, CRISTINA IUGA2, M. BOJIŢĂ2
1Department of Toxicology, University of Medicine and Pharmacy ”Iuliu Haţieganu”, Cluj-Napoca, Romania
2Department of Drugs Analysis, University of Medicine and Pharmacy”Iuliu Haţieganu”, Cluj-Napoca, Romania
* Corresponding author: Tel/Fax: 0040-264-450555
e-mail address: kbela@umfcluj.ro

Abstract:

A high-performance liquid chromatographic method with UV detection at 278 nm has been developed for the quantification of rapamycin in human whole blood samples.
The samples were prepared by liquid-liquid extraction and the chromatographic analyses were performed on a Symmetry ODS column. The method was validated according to the FDA regulation for bioanalytical methods validation. After validation the method was used to evaluate the stability of rapamycin (sirolimus) in whole blood samples.
The methanolic stock solutions of sirolimus and internal standard (32-desmethoxyrapamycin) were found to be stable for at least 1 year when stored at -8°C. Whole blood samples spiked with rapamycin used as calibrators proved to be stable for at least one year when stored at -20°C and -80°C. Extracted samples were stable for up to 48 h. No significant differences were observed between fresh samples and samples reanalyzed after 5 freeze-thaw cycles. .

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