Abstract

Quality by design (QbD) is a part of the design of experiments (DOE) that predict the responses using the software. Identification of critical quality attributes (CQAs) is the first step in QbD. The main concept of QbD is the study of dependent parameters as well as the examination of different factors and their interactions. Hence the present study is designed to develop the QbD-based high-performance liquid chromatography (HPLC) method and validation of diosmin and hesperidin. The experimental design involves the central composite designs (CCDs) of the reverse phase-high performance liquid chromatography techniques with two factors (mobile phase and pH). The Design Expert software 12.0 version was used to produce optimal chromatographic parameters. Agilent Zorbax SB C18 column (250 × 4.6 mm, 5.0 μm), the mobile phase used acetonitrile to mono potassium phosphate (formic acid with pH 2.0) (40:60) with a flow rate of 1 ml/minute and retention times 3.434 minutes of diosmin and 5.321 minutes of hesperidin. According to the International Conference on Harmonisation criteria, the parameters were validated within the specified limits. The QbD-based HPLC method was developed and validated. The utilization of QbD in the present study leads to more precise and reliable data.

Key words: QbD, Central Composite Design, HPLC, Diosmin, and Hesperidin.