The gradient elution program achieved baseline separation of all tested analytes within 8 min, with symmetrical peak shapes and no endogenous interference. The developed method was proven to be free of matrix effects, excellent linearity (R 2 > 0.99 for all analytes), and met international bioanalytical validation criteria across clinically relevant concentration ranges. Notably, this validated method was successfully applied to children receiving mono- or combination therapy for infections. The assay meets requirements for clinical TDM implementation, providing pediatricians with reliable antibiotic concentration measurements within a clinically relevant timeframe.
Zhang et al. (Tue,) studied this question.