Drugs and Metabolites in Biological Fluids

Abstract

A laboratory robotic system designed specifically for automating the sample preparation procedure and chromatographic analysis of drugs and their metabolites in biological fluids has been installed and validated. The system, directly interfaced to a high per-formance liquid chromatograph and data station, has been designed for routine use in pharmacokinetic and disposition studies involving both experimental and marketed non-steroidal anti-inflammatory drugs, as well as several anti-epileptic compounds. PyTechnology architecture, combining new advances in both software and hardware, is utilized to perform all the necessary laboratory operations for the separation of the compounds of interest from the biological matrix and their subsequent chromatographic analysis. Uniform sample treatment and rapid data collection, with minimal human intervention, are achieved through serial sample preparation. The automated procedure is carried out reliably and reproducibly during continuous unattended operation of the system. Validation of the entire automated sample preparation procedure as well as the individual system components was completed over the course of several weeks. The validation data, in addition to the application of the procedure to the analysis of the different compounds in clinical samples, will be demonstrated. Comparisons to the initial manual methods as well as other, older custom robotic systems already in the laboratory will be presented.