A Q-TOF LC/MS method for identification and quantitation of Histamine in the antibiotic Gentamicin at ppm level: Validation and uncertainty evaluation.

•A method to identify and quantify Histamine contamination in Gentamicin medicinal products and active pharmaceutical ingredients by QTOF LC/MS.•Hydrophilic interaction liquid chromatography (HILIC) allowed a perfect separation of Histamine from Gentamicin and preservatives.•High resolution Q-TOF mass spectrometry resulted in the best choice to solve a case of Histamine contamination.•A detailed description of method validation and measurement uncertainty evaluation was presented.