Determination of metallic contaminants in human recombinant erythropoietin (EPO) formulations by adsorptive cathodic stripping voltammetry and UV photo-decomposition of samples

The contamination of renal failure patients by metals can be associated to the presence of toxic metals in the medication, since they can be absorbed by the organism. Among the possible contaminants, there are nephrotoxic metals such as aluminum, chromium and nickel. In the present work, the presence of Al, Cr and Ni as contaminants in erythropoietin formulations (EPO) was investigated by optimizing the adsorptive cathodic stripping voltammetric (AdCSV) method and the photo-decomposition of samples by UV irradiation. The UV irradiation of acidified EPO samples from 2 to 3 h in the presence of H2O2 allowed the efficient sample decomposition and the determination of the contaminants by AdCSV without matrix interferences. The method was applied for the determination of the metals in commercial EPO formulations used routinely in the treatment of anemia in patients undergoing chronic renal failure. The contamination levels determined in the samples ranged from 420.2 to 840.5 ng mL-1 (RSD 2-5%) for Al, 12.0 to 40.0 ng mL-1 (RSD 2-6%) for Cr and 4.1 to 8.2 ng mL-1 (RSD 3-8%). The results obtained by AdCSV were in good agreement with those obtained by the comparative GFAAS measurements. The contamination of EPO formulations with Al, Cr and Ni was shown to be a serious contamination source for anemic patients undergoing chronic renal failure.