Green HPLC-Fluorescence detection method for concurrent analysis of Tamsulosin hydrochloride and Tolterodine tartrate in dosage forms and biological fluids

Abstract

Abstract A novel, environmentally friendly HPLC-FL method has been developed to simultaneously quantify tamsulosin hydrochloride (TAM) and tolterodine tartrate (TTD) in pharmaceutical formulations. The method effectively separates the drugs using an ODS column and gradient elution at a flow rate of 1.0 mL/min. Fluorescence detection was used to measure the relative fluorescence intensity (RFI) of the analytes, with excitation and emission wavelengths set at 280 nm and 350 nm, respectively. The retention times for TAM and TTD were determined to be 5.66 and 7.26 min, respectively. The method’s accuracy and precision were validated according to ICH guidelines. Linear calibration curves were obtained over the concentration ranges of 0.1–1.5 µg mL-1 for TAM and 1–15 µg mL-1 for TTD, with correlation coefficients exceeding 0.9995. The calculated LOD values for TAM and TTD were 0.03 and 0.30 µg mL-1, respectively. The corresponding LOQ values were 0.10 and 0.92 µg mL-1, respectively. The method’s applicability was demonstrated by analyzing pharmaceutical dosage forms and spiked plasma and urine samples. The observed mean recoveries percent were 99.31-100.97% for TAM and 100.56-101.79% for TTD in human plasma, while in human urine, they were 98.71-101.55% for TAM and 99.53-101.84% for TTD. To evaluate the method’s greenness, GAPI and AGREE tools were employed. The results indicated significant adherence to green chemistry principles.