A thorough literature survey revealed that few LC or LC–MS methods are documented for the analysis of VTXTV aldemar et al.reported the use of 11 C-labeling to evaluate the positron emissionin positron emission tomography (PET) radio-ligand of VTXT [5]. Areberg et al. have studied the population pharmacokinetics and pharmacodynamics of VTXT [6]. LC was used for the determination of VTXT, and its impurities were studied using a harsh AcquityUPLC BEH C18 column(2.1 × 150 mm, 1.7 m) with 0.05% v/v trifluoroacetic acid in water as the mobile phase and high temperature[7]. Thus, a simple, sensitive, and effective analytical method needs to be developed to monitor the levels of all possible impurities in VTXT, from both the initial production process and stress degradation, to ensure its safety in the formulations. However, to the best of our knowledge, no studies concerning the formation or identifi-cation of process-related impurities have been reported so far
Several syntheses of VTXT have been published [7–10]; the route shown in Fig. 1 for manufacturing VTXT has several advantagessuch as the use of low-cost materials, a simple preparation process, and good yields [10]. Impurities inevitably form at the end of this process, and include un reacted starting materials, by-products,intermediates, and degradation products. It is essential to carryout identification and structural elucidation of potential impuritiesin drug development. In this study, the potential process-relatedimpurities of VTXT were isolated and then analyzed by HPLC-UV–ESI–MS.