Development and utilization of a combined LC-UV and LC-MS/MS method for the simultaneous analysis of tegafur and 5-fluorouracil in human plasma to support a phase I clinical study of oral UFT®/leucovorin

Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
Cody J PeerWilliam P Petros

Abstract

Tegafur is a 5-fluorouracil (5-FU) prodrug widely used outside the United States to treat colorectal cancer as well as cancers of the head and neck. The resulting plasma concentrations of tegafur are much higher than those of 5-FU; thus, analytical methods are needed that are sensitive enough to detect low plasma concentrations of 5-FU and robust enough to simultaneously analyze tegafur. Previous LC-MS/MS methods have either failed to demonstrate the ability to simultaneously measure low 5-FU and high tegafur plasma levels, or failed to be applicable in clinical studies. Our goal was to develop a method capable of measuring low concentrations of 5-FU (8-200 ng/ml) and high concentrations of tegafur (800-20,000 ng/ml) in human plasma and to subsequently evaluate the utility of the method in patient samples collected during a phase I clinical study where oral doses of either 200mg or 300 mg UF®/LV (uracil and tegafur in a 4:1 molar ratio plus leucovorin) were administered. A combined LC-MS/MS and LC-UV method was developed utilizing negative ion atmospheric pressure ionization (API). The method provides an accuracy and precision of <10% and <6%, respectively, for both analytes. Material recoveries from the liquid-liquid extractio...Continue Reading

References

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Citations

Feb 9, 2016·Indian Journal of Clinical Biochemistry : IJCB·Khushaboo PandeyBhim Bali Prasad
Oct 24, 2014·Biomedical Chromatography : BMC·Yi-Sheng HeChun-Su Yuan
May 31, 2017·The Analyst·Marta BrotoM-Pilar Marco
Apr 22, 2020·The British Journal of Nutrition·Ehab S EshakUNKNOWN Japan Environment and Children’s Study Group
Feb 16, 2013·Clinical Chemistry and Laboratory Medicine : CCLM·Barbara BüchelCarlo R Largiadèr

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