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 the quantitative analysis of Al in monkey serum to assess the systemic exposure to Al.
Keywords:
- alhydrogel
- aluminium
- ICP–MS
- determination