Two facile approaches based on association complex with erythrosine-B for nano-level analysis of duloxetine: application to content uniformity.

Abstract

Duloxetine is an antidepressant that exhibits its action by preventing the reuptake of serotonin and norepinephrine by neurons. In this analytical study, we developed two facile, sensitive methods for duloxetine analysis. Both methods rely on the formation of binary association complex between erythrosine-B and duloxetine in an acidic medium using spectrofluorimetric and resonance Rayleigh scattering (RRS) techniques. Spectrofluorimetric method simply uses the quenching property of the formed complex on the native fluorescence of erythrosine-B at an emission wavelength of 557.2 nm (λex = 528.6), while RRS is based on detecting the enhancement in the RRS signal at 357.2 nm. The proposed methods have been validated according to the International Conference on Harmonization guidelines. The approaches provide linear assay of duloxetine hydrochloride over 0.1–2.4 µg ml−1 and 0.2–2.0 µg ml−1 for spectrofluorimetric and RRS methods, respectively. Variables affecting methods and complex formation were studied and optimized. The limit of detection values were 0.03 and 0.056 µg ml−1 for spectrofluorimetric and RRS methods, respectively. Both approaches were applied with acceptable results for formulation analysis and evaluation of cymbatex capsule content uniformity.