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Updated: May 29, 2026

Setup of Capillary Electrophoresis-Inductively Coupled Plasma Mass Spectrometry (CE-ICP-MS) for Quantification of Iron Redox Species (Fe(II), Fe(III))
Published on: May 4, 2020
Development and validation of an HPLC stability-indicating method for identification and assay of elemental iron(II)
1Merck & Co., Inc., Analytical Chemistry in Development and Supply-Supply Analytical Sciences, Union, NJ 07083, USA. neil.dias@merck.com
Abstract:
Ferrous sulfate tablets are a supplementary iron source for people who suffer from iron deficiency anemia. A simple, fast, and QC-friendly HPLC method was developed and validated to determine elemental iron in ferrous sulfate drug products. A TSK-GEL Super octadecylsilyl column (50 x 4.6 mm id, 2 microm particle size) with a mobile phase consisting of 0.06 M methanesulfonic acid in water-acetonitrile (40 + 60, v/v) and UV detection at 282 nm were used for this method. Separation of the elemental iron peak from the matrix was achieved within 5 min. This method was successfully validated according to International Conference on Harmonization guidelines, and shown to be stability-indicating for the shelf-life samples of ferrous sulfate tablets, as well as selective for the analyte of interest.
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