Analytical quality by design driven development and validation of an UV-visible spectrophotometric method for quantification of Xanthohumol in bulk and solid lipid nanoparticles

INTRODUCTION: Xanthohumol (XH) is a prenylated chalcone available naturally and having diverse pharmacological activities. It has some limitations in the physiological environment like biotransformation, less GIT absorption. To overcome the limitations, we prepared nanoformulations (solid lipid nanoparticles) of XH. Therefore, an analytical method is required for the estimation of XH in the bulk nanoformulations so, we developed and validated QbD based UV-spectrophotometric method as per ICH Q2 (R1) guidelines.
METHODS: The new AQbd based UV-Visible spectrophotometric technique is developed and validated for estimation of xanthohumol in bulk and solid lipid nanoparticles as per ICH guidelines Q2 (R1). The critical method variables (CMVs) are selected based on risk assessment studies. Optimization of method variables was performed by using CCD model.
RESULTS: Multi-regression ANOVA analysis showed R2 value 0.8698 which is nearer to 1 that indicates the model was best fitted. The optimized method by CCD is validated for its linearity, precision, accuracy, repeatability, LOD and LOQ and specificity. All the validated parameters were found to be within the acceptable limits (%RSD<2). The method was linear between 2-12µg/ml concentration with R2 value 0.9981. Method was accurate with % recovery 99.3%-100.1%. The LOD and LOQ was found to be 0.77 and 2.36 μg/mL respectively. The precision investigation was also confirmed the method was precise with %RSD<2.
DISCUSSION AND CONCLUSION: The developed and validated method was applied to estimate the XH in bulk and solid lipid nanoparticles. The developed method was specific to XH which was confined by the specificity study.