Adulteration of synthetic PDE-5 inhibitors viz., sildenafil and tadalafil in marketed herbal aphrodisiacs

Abstract

BackgroundHerbal aphrodisiacs has a long traditional history in all systems of medicine such as Ayurveda, Siddha, and Unani. However, their effectiveness has been questioned time to time. It is believed that action of these herbal and Unani medicines are milder and a prolonged treatment with these therapies is required to cure the problem. With fast onset and quick relief phosphodiesterase-5 (PDE-5) inhibitors were able to overshine these traditional medicines and generated huge profits for their manufacturers. Therefore, in order to increase their sale from herbal aphrodisiacs some of the manufacturers have resorted to malpractices of adulterating their herbal formulations with phosphodiesterase inhibitors. AimThe aim of the study is to find the adulteration of herbal aphrodisiac formulations with synthetic PDE-5 inhibitors. MethodLiquid chromatographic method, namely HPLC, was developed for the qualitative and quantitative analysis of undeclared phosphodiesterase type 5 inhibitors in herbal aphrodisiac preparations. ResultsFifteen herbal aphrodisiac preparations, marketed in Delhi-NCR, were screened for sildenafil and tadalafil. Five of them were found to be adulterated with sildenafil citrate while tadalafil was detected in 14 preparations. HPLC analysis revealed that a single dose of one of the adulterated sample contain 27.95mg of tadalafil. ConclusionThe use of such preparations could result in fatal side effects, particularly with nitrates, knowing that the maximum daily dose for sildenafil and tadalafil is 100mg and 20mg, respectively. Thus, to protect herbal consumers from unethical practicing, more effort should be elicited to make the present regulations more effective.