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Analytical Methodologies for the Determination of Sirolimus: A Review.

Shah Kruti V, Chauhan SP, and Suhagia BN

Sirolimus is a macrolide lactone obtained from fermentations of a solid mold, Streptomyces hygroscopicus. Sirolimus is a potent immunosuppressive agent used to prevent rejection in organ transplantation especially useful in kidney transplants. Sirolimus was approved in 1999, by the US Food and Drugs Administration (FDA) for renal transplants and also known as Rapamycin® (RAPA). A wide variety of analytical methods have been reported for the determination of SRL in biological fluids. Methods for the measurement of Sirolimus in biological fluid have included various chromatographic methods like RP-HPLC-UV, LC-ESI-MS/MS and RP-HPLC-PDA and also included various enzymatic methods like RRA and MEIA by IMx analyzer. The applications of these methods for the determination of Sirolimus in biological sample (human or dog blood) have also been discussed in this article.