Determination of flibanserin in the presence of confirmed degradation products by a third derivative emission spectrofluorometric method: Application to pharmaceutical formulation

摘要

Flibanserin is a new drug used for the treatment of hypoactive sexual desire disorder. This work is considered the first study concerning the fluorimetric behaviour of flibanserin and its new florescent degradation products. A fast, cost-effective, stability-indicating spectrofluorometric method was developed and validated for the determination of flibanserin in the presence of oxidative degradation products. Stability studies are performed to predict the behaviour of substances under various harsh conditions. Thus, flibanserin was subjected to degradation using hydrogen peroxide. The stability-indicating method was developed and validated per ICH guidelines; it was linear in the range of 0.1-3 mu g/mL. The method was accurate and precise as it showed good recoveries between 98.50 and 100.90% and relative standard deviation less than 2%, respectively, and no significant differences were found after statistical comparison with the in-house HPLC method. In addition, the structures of the oxidative degradation products were confirmed using infrared spectroscopy and mass spectrometry, and the proposed degradation pathway was predicted. (C) 2019 Elsevier B.V. All rights reserved.