02600nas a2200241 4500008004100000024000700041245014900048210006900197260001800266300001200284490000700296520177800303653004002081653001002121653004402131653001402175653001902189100002002208700002302228700002102251700002202272856006402294 2023 eng d a0800aAnalytical Quality by Design (AQBD) Assisted Development and Validation of HPTLC Method for Estimation of Rottlerin in Topical Patch Formulation0 aAnalytical Quality by Design AQBD Assisted Development and Valid cFebruary 2023 a267-2760 v153 a

Background: Rottlerin, a natural polyphenolic ketone is a major constituent of Mallotus philippensis (Lam.) Mull. Arg. plant. Although, less explored it has diverse array of therapeutic applications. Objectives: The current work aimed to develop novel, simple, speedy, accurate, potent High Performance Thin Layer Chromatography Method (HPTLC) to separate, and quantify rottlerin from the herbal topical patch In-House formulation. Materials and Methods: This was the foremost attempt to develop and validate HPTLC method using Analytical Quality by design (AQbD) approach. Box Behnken design (BBD) coupled with response surface methodology approach was followed for the systematic optimization. The end results of toluene content, chamber conditioning time, and solvent front on Rf value of rottlerin was studied. The optimised method was validated as per ICH guidelines. Results: For HPTLC, stationary phase used was aluminium plates 60F254 coated with silica gel as. AQbD optimised conditions were mobile phase proportion namely toluene: ethyl acetate: methanol: ammonia (5:4:2:0.2), development distance 80 mm, band width 6mm, and chamber saturation time 10 min. The method generated well resolved and compact bands at Rf of 0.41±0.05. The developed method exhibited high accuracy, precision, robustness, and recovery. The quantity of Rottlerin in developed herbal patch was found to be 134.8 ng/band. Conclusion: In a nutshell, the present study undeniably vouches for a QbD based method development approach for Rottlerin and can be extrapolated to estimate it in other herbal extracts, or marketed formulations

10aAnalytical Quality by design (AQbD)10aHPTLC10aMallotus philippensis (Lam.) Mull. Arg.10aRottlerin10aTopical patch.1 aBodas, Kaumudee1 aShinde, Vaibhav, M1 aVishal, Deshmukh1 aSheetal, Deshmukh uhttps://www.phcogres.com/article/2023/15/2/105530pres152029