Development and Validation of an Inductively Coupled Plasma Mass Spectrometry (ICP-MS) Method for the Determination of 17 Trace Metals in Ingenol Mebutate (API)

Abstract

In this study elemental impurities method of quantitative analysis for the determination of trace metals in Ingenol mebutate (API) by ICP-MS was validated and applied. ICP-MS is a multi-element technique characterized by high selectivity, sensitivity and detection limits much lower than other multi-element techniques. Inductively coupled plasma mass spectrometry (ICP-MS) equipped with microwave digestion is considered an excellent tool for detailed characterization of the elementary composition of many samples. In this study elemental impurities method of quantitative analysis for the determination of toxic metals (As, Cd, Ni, Hg, Pb) and other trace metals Ir, Pd, Pt, Rh, Ru, Os, Mo, V, Cu, Sn, Sb, Bi in Ingenol mebutate (API) using Indium as an internal standard by ICP-MS was validated. Several parameters have been taken into account and evaluated for the validation of method, namely: linearity, the minimum detection limit, the limit of quantification, accuracy and uncertainty. The results obtained for the recovery rates of all (17) metals between 75% and 124 % were found. The detection limits of all elements studied showed the suitability of the procedure for routine analyses. Summarizing it can be concluded that the described analytical procedures to measure the mass fractions of 17 elements in Ingenol mebutate (API) samples with established traceability and evaluated uncertainty allow to obtain reliable and internationally comparable results