A Rapid, Validated High-Performance Liquid Chromatography Method for Simultaneous Quantitation of Phytoconstituents in Asteracantha longifolia (L.) Nees Using a Quality by Design Approach

Asteracantha longifolia (L.) Nees, a small, spiny weed, has effective antitumor, hypoglycemic, aphrodisiac, antibacterial, free radical scavenging, lipid peroxidation, and hepatoprotective properties. It is an essential herb in many traditional and herbal medicines. Active phytoconstituents such as betulin, lupeol, stigmasterol, and β-sitosterol are reported to accord the herb importance as a medicinal plant in modern and traditional medicine. With the implementation of recent regulatory requirements, monitoring raw materials' quality attributes and quantifying the essential phytoconstituents is crucial. Therefore, this article discusses the first-time application of the quality by design (QbD) approach for Asteracantha longifolia (L.) Nees in developing a sensitive, rapid analytical method for the simultaneous quantitation of four bioactive phytoconstituents using high-performance liquid chromatography equipped with photodiode array detector, and validated fully in line with the guidelines by ICH. The QbD approach is an application of risk assessment and determines a design space where the developed analytical method performs at its best compared to traditional methods.