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Publications

Journal Article Ppublish 2 citations

PubMed: 37417199 DOI: 10.4274/tjps.galenos.2022.05335

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

Turk J Pharm Sci 20(3):165-175

Authors: Harish Vancha, Devesh Tewari, Rajesh Kumar, Pilli Govindaiah, Sharfuddin Mohd, Sachin Kumar Singh, Monica Gulati

Affiliations

  • Lovely Professional University, School of Pharmaceutical Sciences, Phagwara, Punjab, India.
  • Delhi Pharmaceutical Sciences and Research University (DPSRU), School of Pharmaceutical Sciences, Department of Pharmacognosy and Phytochemistry, New Delhi, India.
  • Wayne State University, Faculty of Medicine, Department of Pathology, Detroit, USA.

Abstract

Objectives

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.

Materials and Methods

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.

Results

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) <2]. The method was linear between 2-12 g/mL concentration with R2 value 0.9981. Method was accurate with percent recovery 99.3-100.1%. LOD and LOQ were found to be 0.77 and 2.36 μg/mL, respectively. The precision investigation confirmed that the method was precise with %RSD <2.

Conclusion

The developed and validated method was applied to estimate XH in bulk and SLNs. The developed method was specific to XH, which was confined by the specificity study.

MeSH

Nanoparticles, Lipid Nanoparticles