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Determination of ruthenium originating from the investigational anti‐cancer drug NAMI‐A in human plasma ultrafiltrate, plasma, and urine by inductively coupled plasma mass spectrometry
Author(s) -
Brouwers Elke E. M.,
Tibben Matthijs M.,
Rosing Hilde,
Schellens Jan H. M.,
Beijnen Jos H.
Publication year - 2007
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.2985
Subject(s) - chemistry , ruthenium , chromatography , bioanalysis , inductively coupled plasma mass spectrometry , urine , mass spectrometry , pharmacokinetics , pharmacology , biochemistry , catalysis , medicine
We present a highly sensitive, rapid method for the determination of ruthenium originating from the investigational anti‐cancer drug NAMI‐A in human plasma ultrafiltrate, plasma, and urine. The method is based on the quantification of ruthenium by inductively coupled plasma mass spectrometry and allows quantification of 30 ng L −1 ruthenium in plasma ultrafiltrate and urine, and 75 ng L −1 ruthenium in human plasma, in 150 µL of matrix. The sample pretreatment procedure is straightforward and only involves dilution with appropriate diluents. The performance of the method, in terms of accuracy and precision, fulfilled the most recent FDA guidelines for bioanalytical method validation. Validated ranges of quantification were 30.0 to 1 × 10 4 ng L −1 for ruthenium in plasma ultrafiltrate and urine and 75.0 to 1 × 10 4 ng L −1 for ruthenium in plasma. The applicability of the method and its superiority to atomic‐absorption spectrometry were demonstrated in two patients who were treated with intravenous NAMI‐A in a phase I trial. The assay is now successfully used to support pharmacokinetic studies in cancer patients treated with NAMI‐A. Copyright © 2007 John Wiley & Sons, Ltd.