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SN-38 is the active metabolite of anticancer drug irinotecan and displays a strong fluorescence emission.A fluorimetric assay for the quantification of SN-38 in denatured human plasma was developed.A linear range between 10 and 500 ng mL−1 with intra- and inter-day precision and accuracy within the 15% tolerance range were obtained.The comparison of the fluorescent assay for SN-38 with HPLC-MS showed a good agreement between the two techniques.The implementation of therapeutic drug monitoring in the routine clinical practice in oncology is mainly limited by the lack of therapeutic indexes for the majority of the anticancer drugs, and by the absence of suitable analytical tools, which can accurately quantify in real time the concentration of the administered drugs and their relevant metabolites in biological fluids. In this work, a simple and efficient fluorimetric determination of SN-38, the active metabolite of the anticancer drug irinotecan, was developed and applied to human plasma samples. The intrinsic fluorescence of SN-38 allowed its quantification in the range 10–500 ng mL−1 with a LOQ of 5.0 ng mL−1 and a LOD of 1.5 ng mL−1. Low interferences due to main metabolites of irinotecan and comedications, commonly associated with administration of irinotecan, were observed. A validation study, according to FDA and EMA guidelines for bioanalytical method validation, was carried out and, finally, blind samples were analyzed in parallel with a HPLC-MS method obtaining an excellent agreement between the two techniques.