Abstract
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°C) using a mobile phase of acetonitrile:methanol:0.03M ammonium acetate (pH 3.8) (30:15:55, v/v/v), run at a flow rate of 1.5mL/min and detected at 208nm. The best dissolution conditions for this formulation were achieved using a USP apparatus 2 (paddle) at 100rpm and 900mL of phosphate buffer at pH 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.
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