Abstract

UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF DAPOXETINE HCL IN BULK AND TABLET DOSAGE FORM

K. Prashanthi*, A. Sahithi, B. Parijatha, A. Chaitanya and C. Krishna Mohan

ABSTRACT

A simple, economical, accurate, precise and less time consuming UV spectrophotometric method has been developed and validated for estimation of Dapoxetine HCl in bulk and pharmaceutical formulations. In this method, Dapoxetine HCl exhibits maximum absorbance (λ max) at 293 nm. The drug obeys Beer’s law in the concentration range of 10-20 μg/ml. The method was validated as per the International Conference on Harmonization (ICH) guidelines. Drug followed the linearity in the concentration range of 10-20 μg/ml with correlation coefficient (R2) of 0.998. The validity of the proposed method was assessed by applying the standard addition technique where the percentage recovery of the added standard was found to be 100% -109.7%. The limit of detection and quantification were calculated to be 0.084 μg/ml and 0.257 μg/ml respectively. The proposed method is recommended for routine analysis of Dapoxetine HCl in bulk and dosage forms in quality control testing laboratories. Since it is rapid, simple, accurate, sensitive and economical.

Keywords: Dapoxetine, Method Development, ICH and Validation.