Increasing throughput of parallel on-line extraction liquid chromatography/electrospray ionization tandem mass spectrometry system for GLP quantitative bioanalysis in drug development


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Showchien Hsieh 1/*, Tom Tobien2, Kevin Koch1 and John Dunn1 1GlaxoSmithKline, Inc., Research Triangle Park, NC 27709, USA 2Leap Technologies, P.O. Box 969, Carrboro, NC 27510, USA Received 12 September 2003; Revised 18 November 2003; Accepted 18 November 2003

Abstract An approach is described with turbulent flow on-line extraction liquid chromatography/electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) for GLP quantitative bioanalysis of a drug candidate. Two systems were built in-house with standard laboratory parts and equipments. One system consisted of one gradient HPLC pump, one isocratic pump, one ten-port valve, two turbulent flow columns, one analytical column, one autosampler and one mass spectrometer. Using this system, an injection-to-injection cycle time of 0.8 min was achieved. By adding an additional valve, another analytical column and an isocratic pump, the injection-to-injection cycle time decreased to 0.4 min. Validation results from the two systems showed that precision and accuracy were acceptable for GLP quantitative analysis. The system was utilized to support sample bioanalysis of a drug candidate in a first-time in-human clinical trial.

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