Development and Validation of an RP-HPLC Method for The Simultaneous Estimation of Tadalafil and Dapoxetine Hydrochloride in Solid Dosage Forms
Abstract
Tadalafil (a phosphodiesterase-5 inhibitor) and dapoxetine hydrochloride (a selective serotonin reuptake inhibitor) are co-formulated in solid dosage forms, and a simple, validated method for their simultaneous estimation is needed for routine quality control. Objective: To develop and validate an isocratic reversed-phase HPLC (RP-HPLC) method for the simultaneous estimation of tadalafil and dapoxetine hydrochloride in tablets, as per ICH guidelines. Methods: Separation was achieved on a C8 column (150 × 4.0 mm, 5 µm) at 45 °C with a mobile phase of 0.1 M triethylammonium acetate buffer (pH 6.5) and absolute ethanol (42:58), a flow rate of 1.2 mL/min, an injection volume of 10 µL and UV detection at 240 nm. The method was validated for system suitability, specificity, precision, linearity, range, accuracy, solution stability, filter integrity and robustness. Results: Dapoxetine and tadalafil eluted at about 8.0 and 10.1 min, with a resolution of 5.23 and more than 7,000 theoretical plates for each drug. The method was specific, with no interference from blank or placebo. Linearity was obtained over 10.10–30.31 µg/mL for tadalafil and 30.01–90.03 µg/mL for dapoxetine hydrochloride (r = 0.9996 for both). Mean recoveries were 100.40–100.47% (tadalafil) and 99.91–100.75% (dapoxetine hydrochloride), with RSD below 0.5% for tadalafil and below 0.3% for dapoxetine hydrochloride. Method precision RSD was 0.10% and 0.18%. Assay values were 100.20% (tadalafil) and 100.33% (dapoxetine…
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