Abstract
Mirabegron is a novel beta-3 adrenergic receptor agonist in the treatment of overactive bladder disorder. It is a white to slightly yellow crystalline powder with a molecular weight of 396.506 g/mol. Mirabegron is freely soluble in water. In this study, a simple, rapid, precise and accurate High performance liquid chromatography (RP-HPLC) method has been developed on a Shimadzu Model, equipped with SPD-20A UV/Vis detector and prominence LC20AD, C18 (250 mm × 4.6 mm i.d., 3.5 μm particle size) column using isocratic elution of 0.5M potassium di hydrogen ortho phosphate (pH-4.5 adjusted with OPA): Acetontrile (50:50) as mobile phase with 1ml/min flow rate and 280nm wave length . The proposed method was validated as per the ICH guidelines. The present robust RP-HPLC method supports the quantitative analysis of Mirabegron in Bulk and pharmaceutical formulations. Forced degradation studies were performed in different stress conditions such as acidic, basic, oxidation and thermal degradations.
