Monolithic LC method applied to fesoterodine fumarate low dose extended-release tablets：Dissolution and release kinetics

• Published in: Journal of pharmaceutical analysis 2015-04, Vol.5 (2), p.137-141
• Main Authors: Sangoi, Maximiliano S., Todeschini, Vítor, Steppe, Martin
• Format: Article
• Language: English
• Subjects: Dissolution test; Fesoterodine; Low dose extended-release tablets; Monolithic LC; Release kinetics; Short Communication; 低剂量; 单片; 富马酸; 溶解条件; 磷酸盐缓冲液; 缓释片剂; 释放动力学
• ISSN: 2095-1779; 2214-0883
• DOI: 10.1016/j.jpha.2014.10.001

A dissolution test for fesoterodine low dose extended-release tablets using liquid chromatographic（LC） method equipped with a C18 monolithic column was developed and validated. LC system was operated isocratically at controlled temperature（40 1C） using a mobile phase of acetonitrile：methanol：0.03 M ammonium acetate（p H 3.8）（30：15：55, v/v/v）, run at a flow rate of 1.5 m L/min and detected at 208 nm. The best dissolution conditions for this formulation were achieved using a USP apparatus 2（paddle） at 100 rpm and 900 m L of phosphate buffer at p H 6.8 as the dissolution medium.Validation parameters such as the specificity, linearity, accuracy, precision, and robustness were evaluated according to international guidelines, giving results within the acceptable range. The kinetic parameters of drug release were also investigated using model-dependent methods and the dissolution profiles were best described by the Higuchi model. The validated dissolution test can be applied for quality control of this formulation.