High-performance liquid chromatographic method for the determination of a novel thymidylate synthase inhibitor, AG 331, in human serum |
| |
Authors: | Wen Yen Li Dhruba J Chatterjee Bhasker V Shetty Ellen Y Wu Franco Muggia Robert T Koda |
| |
Abstract: | AG 331 is a novel thymidylate synthase inhibitor currently in Phase I clinical trial. To determine the pharmacokinetic parameters of AG 331 in human subjects, a suitable analytical method was developed using high-performance liquid chromatography. Serum and urine samples were prepared using both solid-phase extraction and solvent extraction. Either 4,4′-diaminodiphenyl sulfone or benzcd]indole-2(1H)-one were used as internal standards for the method. A reversed-phase C18 analytical column completely resolved the drug and internal standard peaks from non-specific substances present in biological matrix. The method was validated for precision, accuracy, and reproducibility in serum and was linear over a concentration range of 50–2000 ng/ml, with a limit of detection of 20.0 ng/ml and a quantifiable limit of 50 ng/ml. |
| |
Keywords: | |
本文献已被 ScienceDirect 等数据库收录! |
|