Development and Validation of UV Spectrophotometric Methods for the Estimation of Tadalafil and Dapoxetine Hydrochloride in Bulk and Pharmaceutical Dosage Forms
Abstract
The present study describes the development and validation of simple, accurate, precise, and economical UV spectrophotometric methods for the estimation of Tadalafil and Dapoxetine Hydrochloride in bulk and pharmaceutical dosage forms. Tadalafil exhibited maximum absorbance (λmax) at 283 nm using Dichloromethane (60:40) as solvent system, whereas Dapoxetine Hydrochloride showed λmax at 231 nm using Methanol and Water as solvent system. Beer-Lambert?s law was obeyed in the concentration range of 2-10 ?g/mL for both drugs. The developed methods were validated according to ICH guidelines with respect to accuracy, precision, linearity, ruggedness, limit of detection (LOD), and limit of quantification (LOQ). The proposed methods showed good correlation coefficients, acceptable %RSD values, and satisfactory recovery studies, indicating excellent reproducibility and reliability. The developed UV methods can be successfully applied for routine quality control analysis of Tadalafil and Dapoxetine Hydrochloride in pharmaceutical formulations.
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