Development and validation of a derivative ultraviolet spectrophotometric method for the determination of darifenacin in tablets using experimental designs and its comparison with chromatographic method

摘要

A set of experimental designs was applied to develop and validate a spectrophotometric method using derivative transformation coupled with zero-crossing methodology for the quantification of darifenacin hydrobromide in extended-release tablet form. In the presence of the matricial interference, a central composite (face-centered) design was necessary to reach the best condition without interference in the quantification. The optimal system was confirmed using the function named Derringer's desirability to assess high precision and low quantification limit. The best condition pointed was the first order to derivative transformation, Δλ = 4, scale factor 150, scanning speed 280 nm/s and anulation point in 239.4 nm as wavelength. From these parameters it was possible to perform the method validation resulting in R~2 = 0.999, concentration ranging from 0.10 to 2.50 μg/mL, recovery 98.65% and mean precision 97.67% (RSD = 0.0136). Additionally, robustness was assessed by a Plackett-Burman design, and no significant variability was obtained. The spectrophotometric method was compared with high-performance liquid chromatography method, resulting in no significant difference between the methods.