A novel vardenafil analog in a healthcare product: Preparation, characterization, and quantification

Objective: This study is aimed to develop a qualitative and quantitative method detect novel vardenafil analogue from healthcare product, which claimed enhance sexual function. Method: The unknown compound was detected by non-targeted screening using ultra-high performance liquid chromatography-quadrupole-time-of-flight mass spectrometry (UPLC-Q-TOF-MS). MS2 spectra showed that the characteristic fragment ions of this were highly similar those vardenafil. subsequently isolated silica gel column chromatography characterized 1D (dimension) 2D nuclear magnet resonance (NMR) specta, ultra-violet (UV) spectra, fourier transform infrared (IR) spectra. A for analyzing identified in various product developed based on high-performance chromatography-tandem (HPLC-MS/MS).Results: as 2-(5-((4-ethylpiperazin-1-yl)sulfonyl)-2-propoxyphenyl)-5-methyl-7-propylimidazo.[5,1-f] (Kee et al., 2018; Shin 2022; Kee 2022) [1,2,4]triazin-4(3H)-one spectroscopic data. Quantitative results revealed matrix calibration curves had good linear ranges 2～50 ng/mL pressed candy (R2 = 0.998), energy coffee 0.999), health wine 0.997), respectively. effects, recoveries, limit quantitation (LOQ) all met requirements validation. Finally, content 5 batches positive samples ranged 1.24 7.20 g/kg. Conclusion: analog named it O-propyl vardenafil, distinguished replacement ethyl group with propyl at aryl alkyl ether moiety. Our could meet practical needs. high rate (16.67%) 30 suggested related regulators should be alert routine test since has not been ever before.