Investigation of the association complex formed between dapoxetine and erythrosine-B for facile dapoxetine assay in pharmaceutical formulation using resonance Rayleigh scattering and spectrofluorimetric techniques.

Abstract

Premature ejaculation is a male sexual problem that is marked by rapid ejaculation and quick attainment of orgasm. Dapoxetine belongs to the antidepressant category and modulates its action by preventing the reuptake of serotonin by neurons. Dapoxetine is marketed as an off-label therapy for premature ejaculation. Here, two facile, sensitive, and green compatible approaches were established for dapoxetine assay. The approaches chemically rely on association complex formed between erythrosine-B and dapoxetine in an acidic buffered medium. The quenching effect of the formed complex on the native erythrosine fluorescence at emission 553.5 nm is simply the main idea of spectrofluorimetric assay, while resonance Rayleigh scattering methodology uses augmentation of resonance Rayleigh scattering spectrum at 345 nm by the added dapoxetine. The current approaches exhibit linearity between response and dapoxetine concentration over 0.2-2.5 μg/ml and 0.3-3.0 μg/ml for spectrofluorimetric and resonance Rayleigh scattering (RRS) methods, respectively. All variables affecting methods and complex formation were studied and precisely optimized. The criteria of validation were performed by the directives provided by International Conference on Harmonization's (ICH) Guidelines and limits of detection were 0.06 and 0.05 μg/ml for spectrofluorimetric and RRS techniques, respectively. Finally, the approaches were applied with acceptable results for pharmaceutical formulation analysis.