Screening and Quantitative Determination of A New Vardenafil Derivative in Foods
ZHANG Wanli
ZHANG Liping
LIN Jiechun
LEI Yi
Abstract：A novel derivative of O-propyl vardenafil was identified for the first time in a candy product with aphrodisiac claims using liquid chromatography-high resolution mass spectrometry(LC-HRMS).The compound's molecular structure and fragmentation pattern were deduced from fragment ion data,and further confirmed as vardenafil impurity 31,a derivative of O-propyl vardenafil,based on 1H NMR.Qualitative and quantitative detection methods of O-propyl vardenafil and vardenafil impurity 31 detection were developed using liquid chromatography-triple quadrupole mass spectrometry.Both analytes showed good linearity in the range of 1～50 μg/L.The limits of detection and quantification were 0.05 and 0.1 mg/kg,respectively.Recoveries at three spiked levels in solid drink,candy,oral liquid,and lipid matrix ranged from 87.2%to 113%,with relative standard deviations of 1.1%～8.0%.The method was applied to 234 commercial samples,in which O-propyl vardenafil was detected in 29 batches and vardenafil impurity 31 in 5 batches.Owing to its high sensitivity and accuracy,the method is suitable for qualitative and quantitative determination of illegally added O-propyl vardenafil and its derivative in various food matrices,providing a scientific basis for regulatory monitoring and investigation.
Keywords：vardenafil derivativeillegal additionhigh resolution mass spectrometrytriple quadrupole mass spectrometryfood
Publication Date：2025-11-20
Online Publishing Date：2025-12-26(First online date of this platform, not the publication date of the document)
Pages：7( 341-347 )