Abstract
DEVELOPMENT AND VALIDATION OF UV/ VISIBLE SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF FESOTERODINE IN BULK AND PHARMACEUTICAL FORMULATIONS

Vasanth P.M.*, C. Vara Prasad, G. Reddy Lakshmi Y. Lokesh and Prof. K. Thyagaraju

ABSTRACT

Fesoterodine Fumarate is the competitive muscarinic receptor antagonist with muscle relaxant and urinary antispasmodic properties and rapidly hydrolyzed in vivo into its active metabolite 5-hydroxy methyl tolterodine, which binds and inhibits muscarinic receptors on the bladder detrusor muscle, thereby preventing bladder contractions or spasms caused by acetylcholine. This results in the relaxation of bladder smooth muscle. A simple, sensitive, accurate and reproducible UV/visible spectrophotometric method was developed for the determination of Fesoterodine in bulk and pharmaceutical dosage forms. The solvent used was distilled water and wavelength corresponding to maximum absorbance for the drug was found at 210 nm. Drug obeyed Beer’s law in the concentration range of 10 - 80 μg/ml. with a correlation coefficient of 0.9995. The linear regression equation obtained was y=0.0093x+0.0064, where y is the absorbance and x is the concentration of the pure drug solution. The method was validated for several parameters such as Linearity, Accuracy, Precision and Robustness as per the ICH guidelines. The % recovery value which is close to 100% indicates reproducibility of the method and absence of interference of the excepients present in the formulation.

Keywords: Fesoterodine, Spectroscope, Absorbance, Wavelength.


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