Validated spectrophotometric and spectrofluorimetric methods for determination of dapoxetine hydrochloride and dosulepin hydrochloride in their dosage forms using mercurochrome

Abstract

Validated, simple, rapid and sensitive spectrophotometric and spectrofluorimetric methods were developed for the determination of dapoxetine HCl and dosulepin HCl. The spectrophotometric method (I) was based on a binary complex formation between each drug and mercurochrome (MER) in acetate buffer (pH 3.5) with maximum absorbance at 557 nm. Calibration graphs were linear over the range 2.0-20.0 and 2.0-24.0 μg/ml, detection limits were 0.23 and 0.41 μg/ml and quantitation limits were 0.71 and 1.26 μg/ml for dapoxetine HCl and dosulepin HCl, respectively. Spectrofluorimetric method (II) was based on the measurement of the quantitative quenching effect of each drug on the native fluorescence of MER at the same pH. Fluorescence quenching of MER was measured at 538 nm after excitation at 470 nm. Calibration graphs were linear over the range 0.5-10.0 and 0.4-10.0 μg/ml, detection limits were 0.17 and 0.12 μg/ml and quantitation limits were 0.5 and 0.36 μg/ml for dapoxetine HCl and dosulepin HCl, respectively. Statistical comparison of results with those obtained by reported methods provided good agreement and revealed that there were no significant differences in accuracy and precision between methods. The proposed methods were applied successfully to analyse commercial tablets and capsules containing the studied drugs.

Keywords: Dapoxetine; Dosulepin; Spectrofluorimetry; mercurochrome; spectrophotometry.