Analytical Method Development and Validation for the Simultaneous Estimation of Sildenafil and Dapoxetine by Using RP-HPLC Technique

Prathap.B^1*, V.HariBaskar¹, B.Kumar¹, D.Ramesh², M.Maheswari¹, S.Harika¹, P.Sonalika^1
1Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Nellore, Andhra Pradesh – 524346.
²Department of Pharmaceutical Chemistry, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G Nagar-571448, Mandya, Karnataka.

ABSTRACT
A new RP-HPLC method was developed for the simultaneous estimation of sildenafil and Dapoxetine in pharmaceutical dosage form. The chromatographic conditions were successfully developed for the separation of Sildenafil and Dapoxetine by using Inertsil ODS C18 (4.6 X 250mm X 5µ) column, flow rate was 1.0ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH 4.6: ACN (55:45%v/v) (pH was adjusted with orthophosphoric acid), detection wave length was 255nm. The retention time was found to be 2.984 and 3.525 for sildenafil and dapoxetine respectively. The analytical method was validated according to ICH guidelines. The linearity study for Sildenafil and Dapoxetine was found in concentration range of 1μg/ml to 5μg/ml and 100μg/ml to 500μg/ml and correlation coefficient (r2) was found to be 0.999 and % mean recovery was found to be 99.42% and 100.27%, %RSD for repeatability was 0.77 and 0.48, % RSD for intermediate precision was 0.18 and 0.39 respectively. The proposed method can 必利勁
be used for the routine analysis of sildenafile and Dapoxetine in API and pharmaceutical dosage form.
Keywords: Sildenafil, Dapoxetine and RP-HPLC techniques