Comparative analysis using UPLC and UV methods for concurrent quantification of therapeutic drugs for overactive bladder: Effective approach in green and white chemistry

Abstract

This study evaluates the analysis of Mirabegron (MIR) and Solifenacin (SOL), widely used for treating overactive bladder (OAB), using two direct UPLC and spectrophotometric techniques. These methods were developed to be environmentally friendly, utilizing AGREE, GAPI, AGREEprep, ComplexGAPI, AMGS, ESA, HPLC-EAT, AMVI, and BAGI tools. Spectrophotometry, including the first derivative ratio spectrophotometric method (¹DD), measures SOL and MIR at 224.8 nm and 258.6 nm, respectively. A method known as the extended ratio subtraction method (EXRSM) is used to resolve the overlap between the SOL and MIR. In this method, the binary mixture spectrum is divided by the divisor. A constant value is subtracted from the plateau region. MIR and SOL at λmax of 248.9 nm and 229.8 nm have a zero-order (D⁰) after being multiplied by a divisor. The MCR technique has successfully addressed the issue of spectral overlaps for SOL and MIR at 218.5 and 249.7 nm wavelengths. The second method, UPLC densitometry, separates pharmaceuticals using a UPLC C18 1.7 µm (2.1 × 50 mm) column with Ethanol: phosphate buffer pH 4.2 (35:65 v/v) mobile phase at a 0.6 ml/min flow rate, detecting drugs at 210 nm. Calibration curves for both techniques showed a correlation coefficient greater than 0.999 for SOL and MIR in the 1–65 µg mL⁻¹, 1–60 µg mL⁻¹, and 5–25 µg mL⁻¹, respectively. The methods were validated according to International Conference on Harmonization (ICH) principles. These techniques offer cost-effective, eco-friendly alternatives to traditional methods, promoting sustainability in analytical chemistry.