Stability Indicating Method Development and Validation for the Simultaneous Estimation of Tadalafil and Dapoxetine Hydrochloride by RP-HPLC in Bulk and Tablet Dosage Form
Abstract
Background: A combination of Tadalafil and Dapoxetine hydrochloride is used to manage coexisting erectile dysfunction and premature ejaculation by enhancing erectile response and delaying ejaculation. Objective: For the simultaneous estimation of the drugs Tadalafil along with Dapoxetine hydrochloride in both bulk and tablet dosage forms, a novel stability indication RP HPLC technique has been developed and validated. Method: The technique uses Shim packed 5µm Column18 (4.6×250mm) for separation. Acetonitrile: Water (50:50 v/v), 0.1% TEA, 0.1% OPA (pH 3.5) make up the optimum mobile phase at 1.2 ml/min flow rate, and ultraviolet detection at 264 nm. Results: Dapoxetine hydrochloride and Tadalafil had retention times of 2.1 and 6.2 minutes, respectively. Tadalafil's linearity range was 3–7 µg/ml, whereas Dapoxetine hydrochloride range was 9–21 µg/ml. For both medications, the accuracy ranged from 99.01 to 100.04%. Tadalafil and Dapoxetine hydrochloride had precision of 1.02% and 0.82%, respectively. Tadalafil LOD as well as LOQ are 0.91 µg/ml and 2.76 µg/ml while Dapoxetine hydrochloride are 2.64 µg/mland 8µg/ml. Conclusion:Compared to previously described approaches, the new method is more sensitive, accurate, and precise. Because of the shorter run and retention times, the approach is cost-effective. The resolution for the two analytical substances resulting from forced degradation products (Acid, Base, Hydrogenperoxide, Thermal, and Photolysis) demonstrated the stability…
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