Analytical Quality by Design Driven Development and Validation of UV-Visible Spectrophotometric Method for Quantification of Xanthohumol in Bulk and Solid Lipid Nanoparticles

• Published in: Turkish journal of pharmaceutical sciences 2023-06, Vol.20 (3), p.165-175
• Main Authors: Vancha, Harish, Tewari, Devesh, Kumar, Rajesh, Govindaiah, Pilli, Mohd, Sharfuddin, Singh, Sachin Kumar, Gulati, Monica
• Format: Article
• Language: English
• Subjects: Original
• ISSN: 1304-530X; 2148-6247
• DOI: 10.4274/tjps.galenos.2022.05335

Xanthohumol (XH) is a prenylated chalcone available naturally and has diverse pharmacological activities. It has some limitations in the physiological environment such as biotransformation and less gastrointestinal tract absorption. To overcome the limitations, we prepared nanoformulations [solid lipid nanoparticles (SLNs)] of XH. Therefore, an analytical method is required for the estimation of XH in the bulk nanoformulations, so we developed and validated a quality by design (QbD)-based ultraviolet (UV)-spectrophotometric method as the International Conference of Harmonization (ICH) Q2 (R1) guidelines. The new analytical Qbd based UV-visible spectrophotometric technique is developed and validated for estimation of XH in bulk and SLNs as ICH guidelines Q2 (R1). Critical method variables are selected on the basis of risk assessment studies. Optimization of method variables was performed using the a central composite design (CCD) model. Multiregression ANOVA analysis showed an R2 value of 0.8698, which is nearer to 1, indicating that the model was best fitted. The optimized method by CCD was validated for its linearity, precision, accuracy, repeatability, limit of detection (LOD), limit of quantification (LOQ), and specificity. All validated parameters were found to be within the acceptable limits [% relative standard deviation (RSD)