GREEN RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF TAMSULOSIN AND TADALAFIL WITH GREENNESS ASSESSMENT

Abstract

A streamlined, precise, and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and comprehensively validated for the simultaneous determination of Tamsulosin and Tadalafil in pharmaceutical dosage forms. Separation was achieved on a Platisil C18-SB column (150 × 4.6 mm, 3 μm) using an isocratic mobile phase of 5 mM Ammonium Acetate: Methanol (70:30 v/v) at 0.8 mL/min, with UV detection at 243 nm. Peaks were well-resolved, with optimal retention times and no excipient interference. Adhering strictly to ICH Q2(R1) guidelines, the method displayed linearity (R² >0.999) over 1.6–8 μg/mL for Tamsulosin and 20–100 μg/mL for Tadalafil. Precision was outstanding, as %RSD remained below 2% in repeatability studies. Accuracy was verified via recovery data (98–102%) at 50%, 100%, and 150% levels. Sensitivity excelled, with limits of detection at 0.4 μg/mL (Tamsulosin) and 1.3 μg/mL (Tadalafil), and limits of quantification at 1.3 μg/mL and 4.3 μg/mL, respectively. Specificity and robustness were also confirmed. The greenness of the developed method was assessed using AGREE software, and the method obtained a score of 0.74, indicating good environmental performance. This rapid, reliable RP-HPLC method is eminently suited for routine quality control of Tamsulosin-Tadalafil formulations.