ICP-MS and ICP-OES analysis and validation of some trace elements in alergy and cancer drugs

Many different substances are added to pharmaceutical, food, environmental and cosmetic products for reasons such as providing taste, smell, color and durability, making the appearance of the products interesting and correcting them and ensuring their protection. These substances are called additives and may adversely affect human health depending on the frequency of use and the way they are used. In order to ensure the quality control of human health and medicines, the analyzes of these additives must be carried out completely. For this reason, it is extremely important to develop high-performance, sensitive, fast and low detection limit analysis techniques for the determination of additives. The Elemental Impurities Guide-Q3D of the International Conference on Harmonization represents a new paradigm in the control of elemental impurities in pharmaceuticals. Its approach to the control of elemental impurities has changed to analysis with modern analytical instruments such as inductively coupled plasma-optical emission spectrometry (ICP-OES) and inductively coupled plasma-mass spectrometry (ICP-MS). The management of elemental impurities associated with all finished pharmaceutical products must be implemented in full compliance with pharmaceutical industry regulatory requirements due to quality and safety concerns. In this study, Group 1 Cd, Pb, As, Hg, Group 2A Co, V, Ni, Group 2B Tl, Au, Pd, Ir, Os, Rh, Ru, Se, Pt, Group 3 Li, which are present in cancer and allergy drugs. The analyzes for the presence of elemental impurities of 23 elements such as, Sb, Ba, Mo, Cu, Sn, Cr were carried out by ICP-MS and ICP-OES according to the requirements of pharmacopoeias in accordance with ICH Q3D. Method development and validation studies were carried out in drug samples. Calibration curves for thallium and platinum elements could not be drawn during the analysis with ICP-OES. In addition, due to the low concentrations of arsenic, mercury, rhodium, ruthenium, selenium, cobalt, vanadium, nickel, cadmium and tin elements in drug samples, they were below the detection limits in ICP-OES and ICP-OES appeared to have its own limitations. The method was developed and used to determine the concentrations of 23 elements in drug samples in ICP-MS, providing information that is compared and correlated with the data obtained by the ICP-OES analysis. Microwave digestion technique was used for the analyzes made with both analysis methods. When ICP-MS and ICP-OES analysis techniques are compared in the sample preparation step, the difference in detection limits is clearly seen. Although the applied ICP-OES method is suitable for the determination of a few elements analyzed, more sensitive techniques such as ICP-MS are required for more accurate and reliable analysis in determining the elemental purity in drug samples.