Quantification of Metal(loid)s in Lubricating Eye Drops Used in the Treatment of Dry Eye Disease.

The aim of the study was to evaluate the presence of metal(loid)s in lubricating eye drops used in the treatment of dry eye disease. The concentrations of Al, As, Ba, Cd, Co, Cu, Cr, Pb, Fe, Mg, Mn, Mo, Ni, Se, V, and Zn were determined in 19 eye drop samples using inductively coupled plasma optical emission spectrometry (ICP OES). The limit of detection (LOD) and limit of quantification (LOQ) values for the quantified elements ranged from 0.0002-0.0363 (mg/L) and 0.0007-0.1211 (mg/L), respectively. High values of concentrations of Al (2.382 µg/g), As (0.204 µg/g), Ba (0.056 µg/g), Cd (0.051 µg/g), Co (1.085 µg/g), Cr (0.020 µg/g), Cu (0.023 µg/g), Fe (0.453 µg/g), Mg (24.284 µg/g), Mn (0.014 µg/g), Mo (0.046 µg/g), Ni (0.071 µg/g), Pb (0.049 µg/g), Se (0.365 µg/g), V (0.083 µg/g), and Zn (0.552 µg/g) were quantified in samples of eye drops with and without preservatives. The concentrations of As (5 samples) and Cd (3 samples) were higher than those allowed by the Brazilian Pharmacopoeia for impurities (parenteral use). The value of Co content (µg/g) in a sample was higher than the value established by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH Q3D (R2)) in the parenteral route. The daily eye drop instillation exposure (µg/day) was below the values from the parenteral-permitted daily exposure (PDE) set by the ICH Q3D guideline (R2). The presence of heavy metals in eye drops is an alert to regulatory agencies in several countries so that control and inspections can be carried out.