Development and validation of an HPLC stability-indicating method for identification and assay of elemental iron(II) in pharmaceutical drug products using reversed-phase HPLC.

摘要

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.