Bioanalytical Method Development and Validation of Dapoxetine Hydrochloride in Human Plasma by RP-HPLC

A simple, accurate and rapid Bioanalytical reverse phase high performance liquid chromatography (RPHPLC) method for determination of Dapoxetin hydrochloride in human plasma was validated as per ICH guideline. Dapoxetin hydrochloride is significantly superior in premature ejaculation and more active against serotonin transport inhibitor than any other drug in class. The total analysis was carried out on using stationary phase symmetry C1 (4.6mm X 250mm, 5µm) with Mobile Phase Acetonitrile: Buffer (60:40) pH adjusted to3.5 flow rate was 1.0 ml/min, injection volume of 10 ppm and detection wavelength was 293nm at ambient temperature with total run time of 10 minutes. Retention time of spiked plasma and dapoxetine hydrochloride were found to be 2.153 min and 4.442 min, r2 value were 0.995 and 0.999 and linearity range was 5ppm to 25ppm for both. The method was developed for accuracy, linearity, precision, recovery and stability in complies and stability in complies with CDER and ICH guideline.