Microwave-aided sensitive and eco-friendly HPTLC method for estimation of mirabegron using NBD-Cl as bio-sensing fluorescent probe by Integration of principal component Analysis, response surface modelling and white analytical chemistry approach

Abstract

A large number of analytical methods have been used in in-vivo pharmacokinetic investigations and assays of mirabegron, which is used to treat overactive bladder. Because mirabegron does not give fluorescence, there is no known chromatographic method that uses this property in conjunction with environmentally safe solvents. In order to develop and assess analytical procedures that are precise, sensitive, environmentally friendly, economical, and easy to use, white analytical chemistry was recently presented. Hence, a microwave-aided HPTLC method with fluorescence detection was developed and applied for mirabegron quantification; this method is both sensitive and environmentally acceptable, and it makes use of NBD-Cl, a bio-sensing fluorescent-probe. The analytical-QbD approach, which includes chemometric and response-surface modeling concepts, was used to design this targeted chromatographic method. Critical method variables and performance parameters were identified and optimized using principal component analysis and Box-Behnken design. The targeted method was used to estimate mirabegron through the development of method operable design range navigation and control strategy. A mobile phase consisting of ethyl-acetate and ethanol (8.0 + 2.0, v/v) was used to develop the chromatogram of NBD-Cl derivatised-mirabegron into 8.0 mm bands on a TLC-plate that was supported with aluminum and precoated with silica-gel G60 F254. In a mirabegron concentration range of 50–250 pg/band, the suggested method exhibited linearity. Results showed that the suggested method has a recovery rate of 98 % to 102 %. When estimating mirabegron, the %RSD for the precision and robustness study was determined to be less than 2.0. The mirabegron %assay in the commercially available formulations was determined to be between 98 % and 102 % of the labelled claimed value. Mirabegron had a limit of detection of 10 pg/band and a limit of quantification of 50 pg/band. Marketed tablet formulations of mirabegron had a maximum plasma concentration of 71.58 ng/mL in rats. Using metrics from green analytical chemistry and the RGB model scoring system, we compared the whiteness and greenness profiles of the published and suggested methods. The suggested method was found to be sensitive, eco-friendly, quick, cost-effective, and easy to use for estimation of mirabegron.