Development and validation of a combined liquid chromatography tandem-mass spectrometry assay for the quantification of aprepitant and dexamethasone in human plasma to support pharmacokinetic studies in pediatric patients

A pharmacokinetic study was set up to investigate the pharmacokinetics of anti-emetic agents aprepitant and dexamethasone drug-drug interaction between these drugs in children. In order quantify dexamethasone, a liquid chromatography-tandem mass spectrometry assay developed validated for simultaneous analysis dexamethasone. Protein precipitation with acetonitrile-methanol (1:1, v/v) used extract analytes from plasma. The based on reversed-phase chromatography coupled tandem detection operating positive ion mode. guidelines bioanalytical methods by US Food Drug Administration European Medicines Agency. calibration model linear weighting factor 1/concentration2 over range 0.1–50 ng/mL 1–500 Intra-assay inter-assay bias were within ±20% all at lower limit quantification ±15% remaining concentrations. Dilution integrity tests showed that samples exceeding upper can be diluted 100 times control matrix. Stability experiments compounds are stable biomatrix 25 h room temperatures 89 days −20 °C. This is considered suitable studies will pediatric patients.