Validated stability indicating rp-hplc method for the determination of dapoxetine hydrochloride in bulk and pharmaceutical formulations

Author(s): Sureshbabu Kapavarapu, Rambabu Chintala

Objective: Themain objective was to develope a newvalidated RP–HPLC method for the determination of Dapoxetine hydrochloride in dosage form and to apply the developed method for the analysis of Dapoxetine HCl drug in its dosage forms.An isocratic C18 (Hypersil BDS, 100 mmx 4.6mm, 5µ) column was used with mobile phase of composition. Acetonitrile : Phosphate buffer (40 : 60 at pH=3.0±0.1) at a flow rate of 1.0 mL/min with UV detection at wavelength of 230 nmfor Dapoxetine hydrochloride. The drug was subjected to stress conditions of hydrolysis (acid and base), oxidation, photolysis and thermal degradation. The retention time of the drugwas 4.244minutes. The developedmethodwas validated for specificity, linearity, precision, accuracy, Limit of Detection (LOD), Limit of Quantification (LOQ) and robustness as per International Conference on Harmonization (ICH) guidelines to show the stability indicating power of the method. Linearity was found in the range of 15.0 - 90.0 µg/mL. The percentage recoveries of the drug was ranged from 98 to 102 %. The proposed method could be used for routine analysis of Dapoxetine HCl drug in its dosage forms. The developed method produces high sensitivity, precision and accuracy

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