Method Development and Validation for Simultaneous Determination of 44Ca, 34S, 28Si and 18 Other Trace Elements in Pharmaceutical Packaging Materials’ Extractable Solutions by Inductively Coupled Plasma-Mass Spectrometry (ICP-MS)

Abstract

ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) already issued and implemented Q3D guideline in elemental impurities in final drug products. Consequently, it will be essential to monitor trace elements from packaging material to ensure the final drug product compliance. This study successfully developed a new method for simultaneous identification and quantification of 44Ca, 34S, 28Si and 18 trace elements (27Al, 51V, 52Cr, 55Mn, 56Fe, 58Ni, 59Co, 63Cu, 66Zn, 75As, 78Se, 95Mo, 111Cd, 118Sn, 121Sb, 137Ba, 201Hg and 208Pb) in pharmaceutical packaging materials’ extractable solutions by using ICP-MS in one single method without auxiliary. The method development focused on elemental mass selection, optimization of ICP-MS operational parameters and the sample/standard solutions preparation. Furthermore, the new developed analytical method (accuracy and precision, standard and sample linearity, matrix specificity and robustness of the method) was successfully validated by following US and European compendia criteria. The success of the analytical method development and validation illustrates that the trace elements analysis in pharmaceutical industry becomes feasible per the single ICP-MS method. The analysis of trace elements via this new developed ICP-MS method can provide the worthy information for risk assessment of packaging system and final drug products with relatively low operational cost.