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Certified Spiking Solutions® of Immunosuppressant Drugs
Authors: Uma Sreenivasan, Isil Dilek, Sandra Ybarra, Huahua Jian, Mitzi Rettinger
Presented at Mass Spectrometry Application to the Clinical Lab (MSACL), San Diego, February 2010
Abstract
Immunosuppressant drugs such as Sirolimus, Tacrolimus, Cyclosporin and Mycophenolate mofetil (mycophenolate acid) have a narrow therapeutic index. In addition, they exhibit a wide range of inter-individual pharmacokinetic variability.1 Careful individual monitoring of drug levels in blood is required to optimize prevention of organ rejection while minimizing side effects.
Accurate quantitation of patient drug levels requires robust analytical methods and high quality reference standards. Due to the variability of traditional immunoassay methods, LCMSMS methods have been developed for patient monitoring of these critical therapeutic drugs. There is a need for high quality reference materials with certified values suitable for use in preparation of controls and as calibrators and tuning standards.
Sirolimus, Tacrolimus, and Cyclosporin are complex peptide macromolecules. The materials are toxic and unstable in solution presenting handling and stability challenges.
The goal was to develop high quality certified spiking solutions suitable for use in therapeutic drug monitoring assays and for use as calibration and tuning standards. These pre-made stock solutions would be highly accurate with certified values (not ranges), and would provide convenience of use in a shelf stable format.
1. Kahan, B.D. et al Clinical Therapeutics, 2002, 24, 330-350.
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