Desenvolvimento de metodologia para determinação de canabinoides em produtos à base de cannabis para fins medicinais

DEVELOPMENT OF A METHODOLOGY FOR THE DETERMINATION OF CANNABINOIDS IN CANNABIS-BASED PRODUCTS FOR MEDICINAL PURPOSES

Medicinal products based on the Cannabis sativa plant are available in Brazil, among them, drug, cannabis products, individual import products, and those provided by patient associations. Despite this, there is no monograph for the evaluation of cannabinoids in Brazilian Pharmacopoeia (BP) or other compendia accepted. Therefore, this work aimed to develop a quick and easy method to quantify cannabinoids in authorized products for medicinal purposes. The method was developed by HPLC-UV, gradient elution composed of formic acid in acetonitrile and water, the flow rate of 0.6 mL min^-1 and 220 nm detection. It was possible to resolve the peaks of cannabidiol (CBD), tetrahydrocannabinol (THC), cannabidiolic acid and cannabinol and to quantify CBD (105.35%; 104.07%) and THC (106.62%). The developed method was applied to two products and met the established requirements of precision, accuracy, linearity, and selectivity. This procedure has been tested on four cannabis-based products to attest to its effectiveness. Considering the importance of establishing minimum quality requirements for medicinal products and considering the available products in Brazil, it was found that it is important to evaluate the implementation of other products in the method developed for future validation and later inclusion in the BP.

Keywords:
cannabinoids; quality control; HPLC