Massadeh Adnan M, Abu Hatab Alaa H
Department of Medicinal Chemistry and Pharmacognosy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, 22110, Jordan.
Department of Chemistry, Faculty of Science and Arts, Jordan University of Science and Technology, Irbid, 22110, Jordan.
Biol Trace Elem Res. 2025 Jun 21. doi: 10.1007/s12011-025-04726-7.
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).
止痛药物，无论是非处方（非阿片类）还是处方（阿片类），都存在重金属中毒风险。药品的重金属污染是一个普遍的国际问题；因此，定期检查其安全性至关重要，因为这关系到各种不良健康影响。本研究通过将电感耦合等离子体质谱法（ICP-MS）获得的结果与美国药典（USP）推荐的元素允许限量进行比较，对来自四个选定国家（约旦、阿拉伯联合酋长国、沙特阿拉伯和瑞士）的32种非处方止痛药物（对乙酰氨基酚12个样本、非甾体抗炎药，具体为双氯芬酸16个样本和布洛芬4个样本）中的（铅、镉、砷、铬、铜和镍）元素浓度水平进行了评估。对乙酰氨基酚组中铅、砷和铬元素含量最高，而双氯芬酸组中镉、镍和铜的浓度最高。除了一些约旦、阿联酋的对乙酰氨基酚药物样本中的铅和镉，以及约旦、沙特、瑞士来源的一些双氯芬酸和布洛芬药物样本中的镉外，所有非处方止痛药物样本的检测元素杂质均符合美国药典（USP）推荐的允许限量。验证参数显示出积极结果，包括良好的准确度和良好的相关系数值（R）为0.999以及相对标准偏差（RSD）<5%。数据采用参数单因素方差分析（ANOVA）进行统计分析。对不同化学元素的三类药物类型的均值进行比较表明，除镍（0.017）外，所有p值均>0.05。
