Concentration Levels of Selected Elements in Over-The-Counter Painkiller Medications: A Comparative Study on Different Sources Using Inductively Coupled Plasma - Mass Spectrometry.

Painkiller medicines, either over-the-counter (non-opioid) or prescription (opioid), pose a risk of heavy metal poisoning, Heavy metal contamination of pharmaceuticals is a common and international issue; therefore, it is critical to regularly check their safety as they are connected to a variety of adverse health effects. The elemental concentration levels of (Pb, Cd, As, Cr, Cu, and Ni) of 32 over-the-counter painkillers medications; paracetamol (12 samples) and nonsteroidal anti-inflammatory, specifically diclofenac (16 samples) and ibuprofen (4 samples) from four selected countries; Jordan, United Arab Emirates, Saudi Arabia and Switzerland are evaluated in this research by comparing the results obtained using inductively coupled plasma mass spectrometry (ICP-MS) with the permissible limit of elements recommended by United States Pharmacopeia (USP). The results of Pb, As, and Cr elements were most abundant in the paracetamol group, whereas Cd, Ni, and Cu had the highest concentrations in the diclofenac group. All over-the-counter painkiller medication samples have permissible limits as recommended by the United States Pharmacopeia (USP) of examined elemental impurities except Pb and Cd in some tested Jordanian, Emirati paracetamol medication samples, as well as Cd in some diclofenac and ibuprofen medication samples from Jordanian, Saudi, Swiss sources. The validation parameters demonstrated positive results, including good accuracy and good correlation coefficient values (R) of 0.999 and relative standard deviations (RSD) < 5%. Data were analyzed statistically by using the parametric ONE-WAY (ANOVA). A comparison among the means of the three categories of medication type for different chemical elements indicated that all p-values are ˃ 0.05 except for Ni (0.017).