Quantitative Spectrophotometric Estimation of Dapoxetine Hydrochloride in Pure Form and Pharmaceutical Formulations Using MBTH Reagent
Abstract
A novel simple, selective, rapid and cost effective visible spectrophotometric method was established for the determination of dapoxetine hydrochloride in bulk and in tablet dosage forms. This technique works on the principle of the oxidation of Dapoxetine HCl with acid in presence of 3-methyl-2-benzothiazolinone hydrazone hydrochloride (MBTH) through mediation by ferric ions in weak acidic medium formed by HCl. It forms a stable blue-violet colored compound with wavelength maxima at 612 nm. The factors influencing color development were systematically optimized including the type of acidic medium, the volume of acid, the oxidant, the volume of oxidant, the coupling reagent, the volume of reagent, the order of addition, the reaction time and the temperature. Hydrochloric acid, ferric chloride, and MBTH gave the highly analytical response among the tested variables. Under the optimized conditions, Beer’s law is obeyed over the concentration range of 2.0–20.0 µg mL⁻¹, with the regression equation A = 0.0489C + 0.0618 and a coefficient of determination of 0.9983. The limit of detection and limit of quantification are 0.171 and 0.518 µg mL⁻¹, respectively. The method showed best accuracy and precision, with recoveries close to 100% and relative standard deviation values below 2%. The proposed method is successfully applied to the determination of dapoxetine hydrochloride in commercial tablet formulations without significant interference from common excipients. Therefore, the…
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