An Environmentally Friendly Chromatographic Technique for Estimating Four Co-Administered Medications in Solid Dosage Forms and Human Plasma for the Treatment of Benign Prostatic Hyperplasia

Abstract

Four frequently used medications—tadalafil, dapoxetine hydrochloride, tamsulosin hydrochloride, and solifenacin succinate— for the treatment of benign prostatic hyperplasia and its associated urological disorders, are determined in bulk, tablet dosage forms and human plasma using an environmentally friendly, easy-to-use, affordable, and repeatable high performance liquid chromatographic method (HPLC). The separation by chromatography was carried out on an HILIC column (250 X 4.6 mm, 5 µm) at ambient temperature. Acetonitrile:water (80:20 v/v) was used to achieve separation, with a flow rate of 1.5 mL/min. The run lasted for twenty minutes. Tadalafil, Tamsulosin, Solifenacin were detected at 204 nm and Dapoxetine at 210 nm, using a photodiode array detection. For Tadalafil, Dapoxetine, Tamsulosin, and Solifenacin, the corresponding linearity values were 0.05-100, 0.1-50, 0.2-80, and 0.1-60 μg/mL. The retention times were determined to be 1.683, 5.570, 9.191, and 16.545 minutes. The limits of detection for Tadalafil, Dapoxetine, Tamsulosin, and Solifenacin were determined to be 0.01, 0.02, 0.05, and 0.02 μg/mL, in that order. Low percentage RSD results show good precision in the procedure. It was discovered that the dosage forms recovery percentage fell between 98.50 and 100.61%.The procedure was deemed to be environmentally favorable after being evaluated using two distinct greenness evaluation indices. Thus, routine analysis of the recommended medications in their tablet dosage forms could be effectively conducted using this established and confirmed HPLC approach. Furthermore, a higher sensitivity is provided by the suggested method, making it possible to identify the medications under study in human plasma.