RP-HPLC Method Development Validation for the Concurrent Identification of Tamsulosin and Tadalafil in Pharamaceutical Dosage Form

Abstract

A robust and validated RP-HPLC method was developed for the simultaneous estimation of Tamsulosin and Tadalafil in bulk and pharmaceutical dosage forms, in accordance with ICH Q2(R1) guidelines. Chromatographic separation was achieved using a Spursil C18-EP column (150×4.6 mm, 3 µm) with a mobile phase consisting of 34% perchloric acid and 66% acetonitrile, at a flow rate of 1.0 mL/min and detection wavelength of 223 nm. The method provided sharp and well-resolved peaks with retention times of 3.7 min for Tamsulosin and 4.7 min for Tadalafil. System suitability parameters, including resolution (>2), theoretical plates (>2000), and tailing factor (<2), met all acceptance limits. The method was validated and found to be accurate, with mean recoveries within 98–102%, linear over the ranges 1.6–8 µg/mL for Tamsulosin and 20–100 µg/mL for Tadalafil (R² > 0.999), precise (%RSD <1), sensitive with LODs of 0.02 µg/mL and LOQs of 0.07–0.08 µg/mL. Robustness and ruggedness studies confirmed reliability under small variations in chromatographic conditions, while forced degradation studies demonstrated its stability-indicating capability. Overall, the proposed method is simple, rapid, accurate, and cost-effective, making it highly suitable for routine quality control, stability assessment, and regulatory submission of Tamsulosin–Tadalafil formulations.