DEVELOPMENT AND VALIDATION OF NEW UV METHOD FOR SIMULTANEOUS ESTIMATION OF TADALAFIL IN COMBINATION WITH DAPOXETINE HYDROCHLORIDE IN A PHARMACEUTICAL DOSAGE FORM
T. Sudha*, N. Bhuvaneswari, S. Geetha, S. Mohanapriya, S. Nivedhitha and S. Nanthini
Objective: The present research studies describe development and validation for the simultaneous determination of Tadalafil and Dapoxetine hydrochloride in bulk and in tablet dosage form. Method: Simple UV spectrophotometric method has been developed for simultaneous estimation of Tadalafil and Dapoxetine hydrochloride in bulk and in tablet dosage form. For the method, stock solutions were prepared by using acetonitrile: water (50:50) and the absorbance maxima for Tadalafil and Dapoxetine hydrochloride were found to be 284nm and 292nm respectively. Results: A linear response was absorbed in the range of 1 to 15ug/ml and 3 to 45ug/ml with correlation co-efficent of 0.9997 for Tadalafil and 0.9998 for Dapoxetine respectively. The percentage purity of the tablet formulation was found to be 103.4% and 99.99% for Tadalafil and Dapoxetine respectively. Conclusion: The method was validated for the different parameters like accuracy, precision, sensitivity and linearity as per ICH guidelines Q2 (International Conference Harmonisation). This method can be used for the simultaneous estimation of Tadalafil and Dapoxetine hydrochloride in quality control of formulation without interference of excipients.
Keywords: Simultaneous determination, Tadalafil, Dapoxetine, UV-spectrophotometer, ?max.
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