Dapoxetine HCl, a selective serotonin reuptake inhibitor is a novel drug for premature ejaculation and no dissolution study for its estimation has been reported yet. The aim of this work was to develop and validate a dissolution profile for Dapoxetine HCl in a tablet dosage form using spectrophotometric method. The conditions established for dissolution were: 900 mL of 0.1 N HCl as dissolution medium, using a paddle type dissolution apparatus at a stirring rate of 100 rpm which was able to give % drug release of 96.2666 . The drug release was evaluated by UV spectrophotometric method at 291 nm and a good linearity was observed in the concentration range of 1-6 �µg/mL with correlation coefficient-0.998. The percentage recovery of Dapoxetine HCl was found to be 97.88 �±0.2338 and % CV (0.5713; n=6) indicated a good precision of the analytical method. The limit of detection (LOD) and limit of quantitation (LOQ) were 0.0291 �µg/mL and 0.0882 �µg/mL, respectively. Robustness of the method was performed by using different rotation speeds and doses of the drug. The validation parameters included linearity, accuracy, precision, LOD, LOQ and robustness. The comparison study was performed between dissolution profiles of three different doses of Dapoxetine HCl tablets (30 mg, 60 mg and 90 mg) and the results were recorded. Analytical method validation was found to be within the acceptance criteria of the guidelines of ICH Q2 R1, FDA and FIP. The proposed method can be applied for routine quality control analysis of Dapoxetin HCl.
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