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Nanomaterials 2018, 8(2), 101; https://doi.org/10.3390/nano8020101

Determination of Non-Transferrin Bound Iron, Transferrin Bound Iron, Drug Bound Iron and Total Iron in Serum in a Rats after IV Administration of Sodium Ferric Gluconate Complex by Simple Ultrafiltration Inductively Coupled Plasma Mass Spectrometric Detection

1
U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Translational Science, Office of Clinical Pharmacology, Division of Applied Regulatory Science, Silver Spring, MD 20993, USA
2
U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Office of Testing and Research, Division of Product Quality Research, Silver Spring, MD 20993, USA
*
Author to whom correspondence should be addressed.
Received: 13 December 2017 / Revised: 25 January 2018 / Accepted: 8 February 2018 / Published: 11 February 2018
(This article belongs to the Special Issue Pharmaceutical Nanotechnology)
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Abstract

A rapid, sensitive and specific ultrafiltration inductively-coupled plasma mass spectrometry method was developed and validated for the quantification of non-transferrin bound iron (NTBI), transferrin bound iron (TBI), drug bound iron (DI) and total iron (TI) in the same rat serum sample after intravenous (IV) administration of iron gluconate nanoparticles in sucrose solution (Ferrlecit®). Ultrafiltration with a 30 kDa molecular cut-off filter was used for sample cleanup. Different elution solvents were used to separate each form of iron from sample serum. Isolated fractions were subjected to inductively-coupled mass spectrometric analysis after microwave digestion in 4% nitric acid. The reproducibility of the method was evaluated by precision and accuracy. The calibration curve demonstrated linearity from 5–500 ng/mL with a regression (r2) of more than 0.998. This method was effectively implemented to quantify rat pharmacokinetic study samples after intravenous administration of Ferrlecit®. The method was successfully applied to a pharmacokinetic (PK) study of Ferrlecit in rats. The colloidal iron followed first order kinetics with half-life of 2.2 h and reached background or pre-dose levels after 12 h post-dosing. The drug shown a clearance of 0.31 mL/min/kg and volume of distribution of 0.05 L/kg. 19.4 ± 2.4 mL/h/kg. View Full-Text
Keywords: inductively coupled plasma-mass spectrometry; ultrafiltration; pharmacokinetics; iron; iron gluconate; nanoparticles inductively coupled plasma-mass spectrometry; ultrafiltration; pharmacokinetics; iron; iron gluconate; nanoparticles
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Matta, M.K.; Beekman, C.R.; Gandhi, A.; Narayanasamy, S.; Thomas, C.D.; Mohammad, A.; Stewart, S.; Xu, L.; Chockalingam, A.; Shea, K.; Patel, V.; Rouse, R. Determination of Non-Transferrin Bound Iron, Transferrin Bound Iron, Drug Bound Iron and Total Iron in Serum in a Rats after IV Administration of Sodium Ferric Gluconate Complex by Simple Ultrafiltration Inductively Coupled Plasma Mass Spectrometric Detection. Nanomaterials 2018, 8, 101.

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