Abstract
Aims: A RP-HPLC method was developed and validated for simultaneous estimation of Tadalafil and Dapoxetine applying statistical experimental design.
 Methodology: Multivariate optimization of the experimental conditions of RP-HPLC method was using Design of experiments. Independent three factors like phosphate buffer pH, mobile phase composition and flow rate were applied to design mathematical models. To study the response surface methodology by using Central composite design (CCD). In depth the effects of these independent factors was studied using CCD. Simultaneously optimize the retention time and resolution of the analytes was applying Desirability function.
 Results: The predicted and optimized data from contour picture containing phosphate buffer (pH 3.4) and acetonitrile in the ratio of 40:60%v/v respectively. Flow rate was found to be 0.8 ml/min. Baseline separation of both analytes with run time of less than 10.0 min and good resolution were achieved using these optimum conditions.
 Conclusion: Method was validated according to ICH guidelines by using optimized assay conditions. Therefore, the reports distinctly indicated that Quality by design access could be satisfactorily used to optimize RP-HPLC method for simultaneous estimation of Tadalafil and Dapoxetine.
Highlights
Tadalafil (Fig. 1a) is 2-(1,3-benzodioxol-5-yl)-6methyl-3,6,17-triazatetracyclo heptadeca-1(10), 11,13,15-tetraene-4,7-dione
The reports distinctly indicated that Quality by design access could be satisfactorily used to optimize RP-HPLC method for simultaneous estimation of Tadalafil and Dapoxetine
Extensive literature survey revealed no RPHPLC method has been available for simultaneous determination of Tadalafil and Dapoxetine in bulk and its tablet dosage forms using experimental design access (Quality by Design)
Summary
Tadalafil (Fig. 1a) is 2-(1,3-benzodioxol-5-yl)-6methyl-3,6,17-triazatetracyclo heptadeca-1(10), 11,13,15-tetraene-4,7-dione It is used for the treatment of erectile dysfunction. It is prescribed for the treatment of premature ejaculation [1,2,3,4]. Some Analytical methods has been reported in the literature for the simultaneous determination of tadalafil and dapoxetine bulk and its dosage form by derivative UV, HPTLC, Spectrophotpmetric and RP-HPLC [5,6,7,8]. Estimation of these drugs combination with other drugs or alone has been reported. The aim of the present study for developing simple, rapid, economical and effective method for the simultaneous analysis of tadalafil and dapoxetine applied with DOE and CCD estimation of the developed method
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