Development and Validation of a UPLC Method for Determination of Mirabegron in Tablet Dosage Forms
B. Anupama *
KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada-520010, Andhra Pradesh, India.
A. Viswanath
Vignan Pharmacy College, Vadlamudi - 522 213,Guntur (Dt), A.P, India.
. Azizunnisa
University of Hail, Hail, Saudi Arabia.
Md. Vaseemunnisa
KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada-520010, Andhra Pradesh, India.
*Author to whom correspondence should be addressed.
Abstract
Mirabegron is a drug that is used to treat an overactive bladder. Mirabegron activates the β3 adrenergic receptor in the bladder's detrusor muscle, causing muscular relaxation and bladder capacity expansion. A few measurement procedures have been discovered, but they are inconvenient and time-consuming. The current study developed a simple, exact, precise, and practical UPLC technique for determining the amount of Mirabegron in tablet dosage forms. For the verification of Mirabegron, a simple and specific UPLC approach is applied. On an Acquity BEH C18 (50*3.0mm. 1.7m), chromatographic separation was achieved using a versatile stage containing Potassium di hydrogen phosphate: Methanol(70:30) v/v with a detection wavelength of 254 nm. Mirabegron (r2 = 0.997) showed linearity in the 50-150 g/ml range. The amount of Mirabegron to be employed by the suggested technique matches the label exactly. The proposed technique was validated according to ICH guidelines and used to ensure that the correct amount of medication was present in the dosage form.
Keywords: UPLC, Mirabegron, potassium di hydrogen phosphate, methanol