Abstract

METHOD DEVELOPMENT AND VALIDATION OF SIROLIMUS IN HUMAN WHOLE-BLOOD SAMPLES BY LC-MS/MS

Srinivas Ankanagari,  Tamilselvi Manickam* and Tharuvai Subramanyam Jaishankar

Abstract

Sirolimus is an immunosuppressive agent. It is a macrocyclic lactone produced by Streptomyces hygroscopicus and used in organ transplantation. Our aim was to develop a robust sensitive and selective liquid chromatography-tandem mass spectrometry (LCMS/ MS) method for determination of sirolimus in human whole-blood samples. We used LC-MS/MS system and atmospheric pressure ionization tandem mass spectrometry in the multiple reaction monitoring (MRM) detection mode. The whole blood was collected in the K3EDTA vacutainer taken from healthy human volunteers. Chromatographic conditions and other parameters were suitable for using this method. Total analytical run time was 1.6min, and retention times of analyte and internal standard were 0.88 and 0.86 minutes respectively. This LC-MS/MS method can be preferable for quantification of sirolimus in whole blood sample. Sample preparation was short and simple. It determined sirolimus drug selectively in human whole blood samples.

Keywords: Method development, validation, sirolimus and human whole blood.