Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF AVANAFIL AND DAPOXENTINE HYDROCHLORIDE IN BULK AND DOSAGE FORM

*Raval Kashyap, U.Srinivasa, Kalindi Badodaria

ABSTRACT

To develop and validate a simple, economical, sensitive and accurate Chromatographic (RP-HPLC) Method for simultaneous estimation of Avanafil and Dapoxetine hydrochloride in their combined pharmaceutical dosage form.The HPLC separationwas achieved on a shiseido C18, (250 mm x 4.6 mm i.d. and 5μm particle size) analytical column. A Mixture of acetonitrile:water (90:10, v/v) was used as the mobile phase, at a flow rate of 1 ml/min and detector wavelength at 238 nm. In HPLC method the retention time of Avanafil and Dapoxetine hydrochloride was found to be 2.90 and 4.17min, respectively and the linear dynamic ranges were from 2-12μg/ml and 1.2-7.2μg/ml for Avanafil and Dapoxetine hydrochloride, respectively. Correlation coefficient for method was greater than 0.999. A simple, economic, specific, accurate and sensitive chromatographic (RP-HPLC) method have been developed and validated for the estimation of Avanafil and Dapoxetine hydrochloride in their combined pharmaceutical dosage form. RP-HPLC method validation parameters lie within its acceptance criteria as per ICH Q2 (R1) guideline. Hence, it can be successfully used for the routine analysis of Avanafil and Dapoxetine hydrochloride in their combined pharmaceutical dosage forms.

Keywords: Avanafil, Dapoxentine HCL, CAN, Water and Validation parameter.