ABSTRACT

The QbD methodology has been used to establish a simple, rapid, precise, sensitive, and accurate Reverse Phase High Performance Liquid Chromatography (RP-HPLC) approach for the quantitative measurement of Resveratrol and Pterostilbene in pharmaceutical product. With the use of Design Expert Software, a central composite design was chosen in order to achieve the desired optimum conditions. Ideal chromatographic conditions were obtained on the Waters Alliance-e2695 by using Inertsil ODS 3V (250x 4.6mm, 5?m) column and the mobile phase containing Acetonitrile: 0.1%, Formic Acid in the ratio of 18.9:81.1% v/v at a flow rate of 1.202 ml/min. Pterostilbene and Resveratrol were detected at 273nm using a photodiode array detector with a 10- minutes run time. Pterostilbene and Resveratrol were found to have retention durations of 2.968 and 4.659, respectively. The resolution of 7.57 was obtained. Studies on forced degradation were carried out. All parameters were confirmed to be within acceptable ranges after the suggested approach was validated in accordance with ICH criteria. AGREE software was employed to assess the greenness of the proposed method. The approach developed for the quantitative analysis of Pterostilbene and Resveratrol was found to be simple, eco- friendly, precise, accurate, and robust. Keywords: Pterostilbene, Resveratrol, RP-HPLC, QbD, AGREE
Publication date: 01/06/2025

https://ijbpas.com/pdf/2025/June/MS_IJBPAS_2025_9694.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.6.9694