LC-PDA-MS analysis of dapoxetine and flibanserin

Abstract

Dapoxetine (1) and flibanserin (2) have pharmaceutical effects against premature ejaculation (PE) and hypoactive sexual desire disorder (HSDD), respectively. In international markets, these compounds have been reported as illegal additives in health foods for which tonic effects are implicitly indicated. Therefore, we performed LC-PDA-MS analysis in preparation for the distribution of illegal health foods containing these compounds in Japan. Compounds 1 and 2 were completely separated at r.t. 11.3 and 10.7 min, respectively, under the conditions described as the analytical method for udenafil by the Ministry of Health, Labour and Welfare, Japan. Their spectroscopic data (UV and MS) corresponded to the literature data. Subsequently, we added authentic dapoxetine and flibanserin to an extract of the food supplements with or without an ED treatment agent including sildenafil and tadarafil etc., and then these sample solutions were analyzed using the proposal method. As a result, each compound was completely separated on the UV and mass chromatograms. This study provides useful data for the surveillance of unapproved/unlicensed drugs in health food products.