RP-HPLC method development and validation for the estimation of Vibegron in pure and pharmaceutical dosage form

A novel, precise, accurate, and robust reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of Vibegron in pure and pharmaceutical dosage forms. Chromatographic separation was achieved using a C18 column with an isocratic mobile phase composed of 20 mM ammonium dihydrogen phosphate buffer (pH 3.0) and acetonitrile (60:40 v/v) at a flow rate of 1.0 mL·min⁻¹. Detection was carried out at 254 nm using a UV–VIS detector. The retention time of Vibegron was found to be approximately 5.9 min. The method exhibited excellent linearity in the concentration range of 1-200 µg·mL⁻¹ with a correlation coefficient (r²) of 0.9996. Recovery studies showed values within 98–102%, confirming the accuracy of the method. The developed method was successfully applied for the assay of Vibegron in marketed tablets (Gemtesa® 75 mg). Forced degradation studies confirmed the stability-indicating capability of the method. Validation was performed as per ICH Q2(R1) guidelines, and results demonstrated that the method is suitable for routine quality control analysis of Vibegron in bulk and dosage forms.