Li, Wenkui, Gong, Jiawei, Wang, Chuan, Lin, John and Flarakos, Jimmy (2017) ICP-MS determination of total serum aluminum in monkeys following subcutaneous administration of a drug candidate formulated with Alhydrogel. Bioanalysis, 9 (23). pp. 1873-1881. ISSN 1757-6180

Abstract

Background: To develop and validate an inductively coupled plasma MS (ICP-MS) method for quantitative bioanalysis of aluminum in monkey serum in support of a GLP TOX study with Alhydrogel formulated drug candidate. Methods and results: The method was linear over a dynamic range of 10.0 to 1000 ng/mL using a 50 µL sample volume. The intra-/inter-run precision (%CV) of the QC sample results were ≤ 7.9% (CV) and the accuracy (%Bias) within ±11.0% across all QC 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 aluminum in monkey serum to assess the systemic exposure to aluminum.

Key words:
•ICP-MS: Inductively coupled plasma MS is a technique to quantify one or simultaneously many elements after ionization and mass separation with a mass spectrometer
•Alhydrogel: A compound with many biomedical applications: as a gastric antacid, an antiperspirant, in dentifrices, as an emulsifier, as an adjuvant in bacterins and vaccines, in water purification, etc.

Item Type:	Article
Date Deposited:	02 Jan 2018 00:45
Last Modified:	02 Jan 2018 00:45
URI:	https://oak.novartis.com/id/eprint/33954