Validation and Clinical Application of a New Liquid Chromatography Coupled to Mass Spectrometry (HPLC-MS) Method for Dalbavancin Quantification in Human Plasma

Dalbavancin (DBV) is an intravenous long-acting second-generation glycolipopeptide antibiotic with high efficacy and excellent tolerability, approved for use in the treatment of Gram-positive skin structure infections (ABSSSI). Nevertheless, little known about its pharmacokinetic/pharmacodynamic (PK/PD) properties real life, which also due to technical challenges quantification human plasma, preventing effective application therapeutic drug monitoring (TDM). In fact, DBV has a affinity plasma proteins, possibly resulting poor recovery after extraction procedure. The aim this study was validate simple, cheap reliable HPLC-MS method TDM, accordance FDA EMA guidelines. optimized protein precipitation protocol required 50 μL while chromatographic analysis could be performed 12 min/sample. This fulfilled guidelines requirements then, it applied routine TDM patients receiving off-label doses (two 1500 + mg weekly infusions instead 1000 500 mg), normal renal function or undergoing hemodialysis: continuous hemodiafiltration caused relevant reduction exposure, intermittent dialysis showed comparable concentrations those function. confirmed eligibility presented usefulness clinical practice.