QUALITY-BY-DESIGN (QBD) APPROACH TO CHROMATOGRAPHIC CONDITIONS APPLIED FOR DETERMINATION OF ROBUSTNESS IN SILYMARIN EXTRACT
Authors: Chopade V.V , UTTEKAR P.S, GAWADE.V.S, CHAVAN S.U AND BASTIA .S.B

ABSTRACT
In the present study Quality by design approach was implemented for HPTLC method development and validation for robustness. Silymarin found in highest concentration in fruit portion. Silymarin is a flavolignan from Silybum marinum plant used for hepatoprotection. Silymarin extract and Silybin were used in the study. Chloroform, ethyl acetate, acetone, formic acid was used for mobile phase optimization.HPTLC method developed and validated. All data analysis of experimental design were performed by using the Design-Expert trial version 7.0.0 (Stat-Ease Inc., Minneapolis, MN,USA) and Box-Behnken method was used for the optimization of chromatographic conditions. Mobile phase ratio, solvent front and chamber saturation time were determinate as critical method parameters.Method was developed and validated using solvent on silica as chloroform: ethyl acetate: acetone: formic acid (40:30:20:10, v/v) (Rf of silybin 0.15 ± 0.03) At 296 nm in the absorbance mode. The technique demonstrated a strong linear relationship (r2 = 0.9983) in the concentration 250, 500, 750, 1000, 1250 and 1500 ng/ band of Silybin, respectively.It was found that it was linear, accurate, precise and robust. Keywords: Silybin, silymarin extract, Box- Behnken, flavolignan, hepatoprotection
Publication date: 01/08/2022
    https://ijbpas.com/pdf/2022/August/MS_IJBPAS_2022_6336.pdf
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https://doi.org/10.31032/IJBPAS/2022/11.8.6336