High‐performance thin layer chromatographic method development and validation for simultaneous estimation of solifenacin succinate and silodosin using quality by design approach and greenness assessment

Abstract

AbstractThe current research developed a high‐performance thin layer chromatographic method based on green analytical chemistry and integrated experimental approaches of analytical quality by design for simultaneous estimation of solifenacin succinate and silodosin. The integration was planned to reduce energy and solvent usage, maximize efficacy, and minimize any negative environmental effects. Taguchi design for screening and optimization a Box–Behnken design was used. The n‐butanol:ethanol:triethylamine (6:4:0.1, v/v/v) mobile phase and ultraviolet detection at 221 nm were used to develop the method. As per International Council for Harmonization Q2(R1) specifications, the method was validated. Rf value for solifenacin succinate and silodosin was found to be 0.29 ± 0.02 and 0.58 ± 0.02 respectively. For solifenacin succinate and silodosin, the linearity was found over the concentration ranges of 500–2500 ng/band and 800–4000 ng/band. For solifenacin succinate, the limits of detection and quantification were found to be 13.00 and 39.34 ng/band, respectively, while for silodosin, they were 33.29 and 100.86 ng/band, respectively. For solifenacin succinate, the method revealed a percent recovery ranging from 98.49% to 99.50%, while for silodosin, it exhibited a range from 98.86% to 99.79%. The tools predicted greenness score to be 63 and 0.78, respectively, indicating the proposed method to be green.