Paper Title
ELEMENTAL IMPURITIES ANALYSIS OF METRONIDAZOLE API USING ICP-OES

Abstract
Introduction: Due to the dangerous nature of heavy metals and the inadequate performance of their limit test, especially for highly toxic elements, this test has been deleted in all specific pharmacopoeia monographs and replaced by the guideline for elemental impurities (ICH Q3D) at as of the 9th edition Eur Ph and USP 40-NF 35. In January 2018, this guideline became applicable to all drugs. The objective of this work was to analyze the elemental impurities in six samples of Metronidazole Actif Pharmaceutical Ingredient (API) coming from pharmaceutical producers located in Algeria, by applying the novel techniqueof Inductively Coupled Plasma-Optical Emission Spectrometry (ICP-OES). Material and Methods: Six samples of Metronidazole API were collected from 27 requested producer laboratories. They are all analyzed by the novel elemental impurity detection technique using the branded ICP-OES device (Thermo Scientific iCAP 7000 Series) and Single Element Standard Solutions of the following: Cd, Pb, As, Hg, Co, Ni, Ag, Cu, Sn, Cr and the guideline operating protocol (ICH Q3D) of the United States Pharmacopeia (USP 40-NF 35) was used. Results and Discussion: The elements content of class 1 (Cd, Pb, As and Hg), of class 2 (Co, Ni and Ag) and of class 3 (Cu, Sn and Cr) is in conformity in all the samples collected with limits required by the latest edition of USP 40-NF 35 with the exception of M3 sample which has an excess of 1,5 ppm in Ni compared to the parenteral route. Conclusion: The excess Nickel detected in M3 sample confirms the fact that still raw material manufacturers use the traditional method of heavy metal analysis known as a limit test. It is therefore essential to apply new procedures based on security data, such as ICP-OES or ICP-MS. Keywords - Elemental Impurities, Heavy Metals, ICP-OES, Actif Pharmaceutical Ingredient.