Validación de un método analítico para la determinación del contenido de CANNABIDIOL (CBD) en inflorescencias por cromatografía liquida de alta resolución con detector de arreglo de DIODOS (HPLC/DAD)

Abstract

CONDITION FOR PUBLICATION OF PROJECT. Scientific interest in the Cannabis sativa plant, its metabolites and potential therapeutic applications has experienced an unprecedented boom in the last decade. Due to its medicinal properties, cannabidiol (CBD), has become the main cannabinoid of numerous studies, thus boosting research in both clinical and analytical fields; inflorescences, containing the highest metabolic load, are the main useful matrix for the subsequent extraction of the analyte, generation of extracts, derivative products and for the research enrichment that arises around CBD in the laboratory. The focus of this research was the development and validation of an analytical method to determine the CBD content in inflorescences by high performance liquid chromatography with diode array detector (HPLC-DAD), the different validation parameters were evaluated according to the AOAC 2018.10 standard, allowing to obtain results that guarantee the analytical competence in each test with confidence and veracity, which support the quality of the laboratory. The results obtained for each of the quality parameters allowed satisfying each validation objective, obtaining a selective method with a resolution greater than 1.5; for LOD: 0.29 mg/g, LOQ: 0.87 mg/g; the linearity evaluated per day exceeded an 𝒓𝟐 of 0.995; the %RSDr for both high level and low level was 1.45% and 4.76% respectively; for %RSDi at high level 3.43% was obtained and low level 3.67%; the recovery for low level was 93.56% and high level 99.14%; finally in robustness the method resulted sensitive to variations. According to the results reported for each parameter, the method developed for the laboratory of Medicinal Chemistry of the University of Azuay is validated with its respective recommendations. Keywords: CBD, HPLC-DAD, cannabinoids, validation, quality.