Development and Validation of UV Spectrophotometric method for estimation of Dapoxetine HCL in bulk and dosage Form

Dapoxetine HCl, a selective serotonin reuptake inhibitor is a novel drug for premature ejaculation and no spectrophotometric method for its estimation has been reported yet. The aim of present work is to develop and validate simple, accurate, sensitive, reproducible and specific spectrophotometric method for the determination of Dapoxetine HCl, in bulk and its pharmaceutical formulations, using methanol as a solvent. The optimum conditions for the analysis of the drug were established and the developed method was validated with respect to linearity, accuracy (recovery), precision, robustness, ruggedness, LOD, LOQ and specificity. The maximum wavelength (% max) was found to be 291 nm and a good linearity was observed in the concentration range of 5-60 μg/mL having regression equation, y = 0.0164x – 0.0071 with correlation coefficient of 0.9998. The percentage recovery of Dapoxetine HCl was found to be 99.5489 ±0.1599 and % CV (0.16; n=9) indicated a good precision of the analytical method. The limit of detection (LOD) and limit of quantitation (LOQ) were 0.0239 μg/mL and 0.0724 μg/mL, respectively. Robustness and ruggedness of the method was performed by using different % max, instruments, apparatus and analysts. The method was found to be simple, accurate, precise, reproducible, economical and robust. Analytical method validation was found to be within an acceptance criteria according to ICH Q2 R1 guidelines. The proposed method can be applied for routine quality control analysis of Dapoxetine HCl.

Author(s): Kanani Vineeta V, K. S. Muralikrishna

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