UV spectrophotometry and HPLC quantification of vibegron: evaluating whiteness, greenness, and blueness

Vibegron is a beta-3 adrenergic agonist receptor used in the treatment of overactive bladder. Present study aims to develop and validate enviornmentally sustainable UV spectrophotometric and Chromatography methods for the quantitative analysis of the Vibegron in both bulk drug substances and products, addressing the current lack of established quantification methods. The UV spectrophotometric method was developed using Acetonitrile as the solvent at a wavelength of 248 nm. While the HPLC method contained, Kromasil Classic C18 (250 mm*4.6 mm*5 µm) column, detection wavelength 248 nm, mobile phase composition Acetonitrile and Ammonium Acetate buffer 4.5 pH 44:56 (v/v) atflow rate of 0.8 mL/min, and injection volume 10 µL. The ICH Q2 (R2) guideline is followed to validate developed methods, including parameters like specificity, linearity, range, accuracy, assay, precision, LOD, LOQ, and robustness. The UV spectrophotometric and HPLC methods demonstrated strong linearity with R² = 0.9993 and 0.9972, respectively. The percentage recovery for accuracy and assay at each level was between 98 and 101% for both methods. Results were found to be consistent with an RSD < 2 for both methods for precision and robustness parameters. LOD was found to be 0.6520 µg/mL and 0.5767 µg/mL, and the LOQ was found to be 1.9759 µg/mL and 1.7476 µg/mL, respectively, for the UV and HPLC method. Sustainability assessment using standard tools revealed that the UV spectrophotometric method is greener and more economical, whereas, HPLC offers higher precision with increased cost and environmental impact. The methods ensure quality control, regulatory compliance, and sustainable, cost-effective analysis.