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Increasing throughput of parallel on‐line extraction liquid chromatography/electrospray ionization tandem mass spectrometry system for GLP quantitative bioanalysis in drug development
Author(s) -
Hsieh Showchien,
Tobien Tom,
Koch Kevin,
Dunn John
Publication year - 2004
Publication title -
rapid communications in mass spectrometry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.528
H-Index - 136
eISSN - 1097-0231
pISSN - 0951-4198
DOI - 10.1002/rcm.1327
Subject(s) - chemistry , chromatography , bioanalysis , electrospray ionization , electrospray , mass spectrometry , tandem mass spectrometry , liquid chromatography–mass spectrometry , extraction (chemistry) , analytical chemistry (journal)
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 analyses. The system was utilized to support sample bioanalysis of a drug candidate in a first‐time in‐human clinical trial. Copyright © 2004 John Wiley & Sons, Ltd.