title: 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.
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.
authors.affiliation: Merck & Co., Inc., Analytical Chemistry in Development and Supply-Supply Analytical Sciences, Union, NJ 07083, USA. neil.dias@merck.com
authors.forename: Neil C
authors.initials: NC
authors.lastname: Dias
authors.forename: Abu M
authors.initials: AM
authors.lastname: Rustum
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D005296:Ferrous Compounds / Q000737:chemistry; D007501:Iron / Q000737:chemistry*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013607:Tablets / Q000737:chemistry
chemical_list: D005296:Ferrous Compounds; D013607:Tablets; C020748:ferrous sulfate; D007501:Iron