ICP–MS determination of serum aluminum in monkeys subcutaneously administered an alhydrogel-formulated drug candidate
Digital explosion of news articles and data from a computer screen, symbolizing information overload, digital chaos, and media consumption
Aim: To develop and validate an inductively coupled plasma–mass spectrometry method for quantitative bioanalysis of aluminum (Al) in monkey serum in support of a GLP TOX study with alhydrogel-formulated drug candidate. Methods & results: The method was linear over a dynamic range of 10–1000 ng/ml using a 50-μl sample volume. The intra-/inter-run precision (%CV) of the quality control sample results were ≤7.9% (CV) and the accuracy (%bias) within ±11.0% across all quality control concentrations evaluated. Other validation parameters, including stability under various conditions, extraction recovery and matrix effect, all met the acceptance criteria. Conclusion: The validated method was successfully implemented for...