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lüll Analytical validation of accelerator mass spectrometry for pharmaceutical development Keck BD; Ognibene T; Vogel JSBioanalysis 2010[Mar]; 2 (3): 469-85The validation parameters for pharmaceutical analyses were examined for the accelerator mass spectrometry measurement of (14)C/C ratio, independent of chemical separation procedures. The isotope ratio measurement was specific (owing to the (14)C label), stable across samples storage conditions for at least 1 year, linear over four orders of magnitude with an analytical range from 0.1 Modern to at least 2000 Modern (instrument specific). Furthermore, accuracy was excellent (between 1 and 3%), while precision expressed as coefficient of variation was between 1 and 6% determined primarily by radiocarbon content and the time spent analyzing a sample. Sensitivity, expressed as LOD and LLOQ was 1 and 10 attomoles of (14)C, respectively (which can be expressed as compound equivalents) and for a typical small molecule labeled at 10% incorporated with (14)C corresponds to 30 fg equivalents. Accelerator mass spectrometry provides a sensitive, accurate and precise method of measuring drug compounds in biological matrices.|Animals[MESH]|Drug Contamination[MESH]|Drug Discovery/*methods[MESH]|Humans[MESH]|Linear Models[MESH]|Mass Spectrometry/*methods[MESH]|Pharmaceutical Preparations/analysis/metabolism[MESH]|Reproducibility of Results[MESH] |