Abstract

STABILITY INDICATING HPTLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF VIBEGRON IN PHARMACEUTICAL DOSAGE FORM

Vidhan Barot*, Dr. Pruthviraj K. Chaudhary, Mrs. Sweety G. Oza, Dr. Khushbu K. Patel, Dr. C. N. Patel

ABSTRACT

Vibegron is a novel and selective β3-adrenergic receptor agonist approved for the treatment of overactive bladder (OAB), a condition characterized by urinary urgency, frequency, nocturia, and urge urinary incontinence. The drug improves bladder storage capacity by relaxing the detrusor muscle through stimulation of β3-adrenergic receptors. Accurate and reliable analytical methods are essential for the determination, quality control, and stability assessment of vibegron in pharmaceutical formulations and biological samples. The present review summarizes the pharmacological profile, mechanism of action, pharmacokinetics, and various reported analytical methods for the estimation of vibegron. Several analytical techniques including UV spectrophotometry, high-performance liquid chromatography (HPLC), and liquid chromatography–tandem mass spectrometry (LC-MS/MS) have been reported for its quantification. These techniques differ in terms of sensitivity, selectivity, accuracy, and applicability for routine analysis. This review highlights the importance of developing simple, precise, accurate, and stability-indicating HPTLC methods for reliable determination of vibegron in pharmaceutical dosage forms. 

Keywords: Vibegron, Overactive Bladder, ?3-adrenergic receptors, HPTLC, LC-MS/MS, Analytical Method.