Development of multi-elemental method for quality control of parenteral component solutions using ICP-MS

Abstract

An inductively coupled plasma mass spectrometry (ICP-MS) method for elemental impurities determination in components used for parenteral nutrition solutions is proposed. Solutions of amino acids (10% m/v), glucose (50% m/v) and lipids (20% m/v) were analyzed. Arsenic, Cd, Cu, Pb and Mo were determined by ICP-MS operated at standard mode, whilst pneumatic nebulization was used for introducing the sample solution into the ICP. Mercury was determined using cold vapor generation (CVG) coupled to ICP-MS. Chromium, Mn, Ni and V were determined by means of dynamic reaction cell-inductively coupled plasma mass spectrometry (DRC–ICP-MS), while ammonia was used as reaction gas. The operational conditions of each technique were optimized in order to achieve better sensitivity, precision and accuracy. The influence of the sample matrix, mainly carbon, on all investigated elements was evaluated. The use of DRC was effective to reduce interferences on Cr, Mn, Ni and V determination. The other investigated elements (As, Cd, Cu, Pb, Mo and Hg) were determined directly in the samples, which were properly diluted. Results obtained were in good agreement (between 96 and 103%) with certified values (certified reference materials of water were analyzed), at the same time as the relative standard deviation was lower than 5%. Sample throughput was relatively high (up to 30 samples of components used for parenteral nutrition solution could be analyzed per hour). In this way, the proposed method can be recommended for routine analysis.