Proposal for an analytical methodology for the determination of Arsenic and Selenium in sodium saccharin dihydrate by the HG-ICP OES technique
DOI:
https://doi.org/10.5281/zenodo.8028618Keywords:
Geração de hidretos, impurezas elementares, sacarina sódica, icp oes, método analítico, controle de qualidade, medicamentosAbstract
Interest in the determination of elemental impurities in pharmaceuticals has increased in recent years due to changes in regulatory requirements and the need to update current limit tests recommended in pharmacopoeias. Inductively coupled plasma optical emission spectrometry (ICP) is a suitable alternative for multielement analysis. The objective of this article is to harmonize the analysis implemented by the manufacturer and the pharmaceutical industry for the quality control of the raw material saccharin sodium dihydrate; through the development of an analytical methodology in the hydride generation technique by ICP OES quantifying Arsenic (As) and Selenium (Se) in the study matrix. It was necessary to use different analyte reduction steps to form the respective volatile hydrides. For this reason, it was decided to carry out the analyzes separately. For As, the reaction was carried out in an acid medium, using potassium iodide and ascorbic acid, while for Se, the reduction of Se+6 to Se+4 was carried out by heating in an acid medium. Results were obtained for Precision and Accuracy within the acceptance criteria described by USP<730>, thus the test proved to be promising, presenting a relative standard deviation of 2.0% and 2.6%, for As and Se respectively, and the linearity expressed correlation coefficient of 0.99. In future studies, it is intended to continue the analytical validation phase, which will be evaluated by the parameters described in RDC 166/2017, meeting the requirements established by current legislation and other international guidelines.
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