Rosolina Samuel M, Chambers James Q, Lee Carlos W, Xue Zi-Ling
Department of Chemistry, University of Tennessee, Knoxville, TN 37996, USA.
Pfizer, Inc., Analytical Research and Development, PharmaTherapeutics Pharmaceutical Sciences, Groton, CT 06340, USA.
Anal Chim Acta. 2015 Sep 17;893:25-33. doi: 10.1016/j.aca.2015.07.010. Epub 2015 Aug 8.
A new electrochemical method has been developed to detect and quantify the elemental impurities, cadmium(II) (Cd(2+)) and lead(II) (Pb(2+)), either simultaneously or individually in pharmaceutical matrices. The electro-analytical approach, involving the use of anodic stripping voltammetry (ASV) on an unmodified glassy carbon electrode, was performed in both aqueous and in a 95/5 dimethyl sulfoxide (DMSO)/water solutions, without acid digestion or dry ashing to remove organic matrices. Limits of detection (LODs) in the μg L(-1) [or parts per billion (ppb), mass/volume] range were obtained for both heavy metals - in the presence and absence of representative pharmaceutical components. To the best of our knowledge, the work demonstrates the first analysis of heavy metals in DMSO/water solutions through ASV. The strong reproducibility and stability of the sensing platform, as well as obviation of sample pretreatment show the promise of utilizing ASV as a sensitive, robust, and inexpensive alternative to inductively-coupled-plasma (ICP)-based approaches for the analysis of elemental impurities in, e.g., pharmaceutical-related matrices.
一种新的电化学方法已被开发出来,用于检测和定量药物基质中镉(II)(Cd(2+))和铅(II)(Pb(2+))这两种元素杂质,可同时或单独检测。该电分析方法采用未修饰的玻碳电极上的阳极溶出伏安法(ASV),在水溶液以及95/5的二甲基亚砜(DMSO)/水溶液中进行,无需酸消解或干法灰化来去除有机基质。在有代表性药物成分存在和不存在的情况下,两种重金属均获得了微克每升[或十亿分之一(ppb),质量/体积]范围内的检测限(LOD)。据我们所知,这项工作首次通过ASV对DMSO/水溶液中的重金属进行了分析。传感平台的强重现性和稳定性,以及无需样品预处理,表明利用ASV作为一种灵敏、稳健且廉价的替代方法,可用于分析例如药物相关基质中的元素杂质,以替代基于电感耦合等离子体(ICP)的方法。