Validated QuEChERS-HPLC-UV Method for Quantification of Cannabidiol in Pharmaceutical Nanoformulations.

Chaobon P.; Bunwatcharaphansakun P.; Supattanachote G.; Namdee K.; Ngernsutivorakul T. · ChemPlusChem · 2026

**Background & Methods** This study describes the development and validation of a QuEChERS-HPLC-UV analytical method for quantifying cannabidiol (CBD) in pharmaceutical nanoformulations according to ICH guidelines. The method was tested using two representative matrices: spray-dried CBD-loaded lipid nanoparticle (CBD-LNP) powder and Dulbecco's modified Eagle medium (DMEM) for cell-based assays, with subsequent application to stability testing and cellular uptake studies. **Key Findings** • The validated HPLC-UV method demonstrated excellent analytical performance with linearity >0.999 (R²) across 1-100 µg/mL range for both matrices, limits of detection of 0.15-0.17 µg/mL, and limits of quantification of 0.46-0.51 µg/mL, with minimal matrix effects and CBD recoveries exceeding 90% in both matrices. • Intra-day and inter-day precision showed acceptable reproducibility with relative standard deviation values below 2.8% and 7.8%, respectively, indicating the method's reliability for routine quality control applications. • Stability testing of nanoformulated CBD products (3% and 5% formulations) identified 25°C as the optimal storage temperature over a 6-month period, and cellular uptake studies demonstrated superior bioavailability of the nanoformulated CBD compared to isolate and oil-based forms. **Dosage & Administration** Not reported. This is an analytical methodology paper; clinical dosing information is not addressed. **Safety & Adverse Effects** Not reported. This study focuses on analytical method validation and does not evaluate safety or adverse effects in clinical or preclinical models. **Evidence Quality** This is a methodology validation study (analytical chemistry research) rather than a clinical or preclinical efficacy/safety investigation. The work demonstrates strong technical rigor through ICH guideline compliance and comprehensive validation parameters. However, evidence quality is limited by the lack of clinical data, animal studies, or human safety assessments. The findings support pharmaceutical quality control and nanopharmaceutical research development but do not provide evidence regarding therapeutic efficacy or clinical safety of CBD nanoformulations in human subjects.

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