Title: Stability study of cannabidiol in selected medicinal formulation by chromatographic techniques
Analysis of plant extracts provides valuable information on natural occurrence of pharmacologically important compounds. Their application is possible in a wide range of sectors, starting with medicine, pharmacy, cosmetic and food industry, but usability is greatly influenced by their stability. For this reason, stability studies which allow the evaluation of the stability of an active pharmaceutical substance (API) or the finished medicinal product are an essential part of pharmaceutical development1. According to International Conference on Harmonization guidelines (ICH), stress studies are mostly performed on a single dose of API and must include the effects of temperature (increase of 10 °C above the accelerated test temperature), humidity (75% relative humidity or higher), light (photolysis) and air oxygen2. Based on obtained data, the active substance should be evaluated under storage conditions (with appropriate tolerances) to verify its thermal stability and moisture sensitivity. Currently, the analysis of bioactive substances extracted from Cannabis is a topic of considerable interest, although sensitive, selective and available methods for qualitative and quantitative analysis are required. Advanced analytical techniques are therefore particularly important for the effective monitoring of analytes, their metabolites and degradation products, especially at low and trace concentrations. In the present work, a reversed-phase HPLC-MS method was developed for simultaneous analysis, quantification, and qualification of CBD and its possible degradation products. After verifying the applicability of the method in preliminary experiments, the stability tests of CBD were performed in accordance with ICH rules. CBD samples exposed to stress conditions in the form of CBD-oil matrix were found to be nearly complete degraded during the six-month study, while the plain API samples remained unchanged.
Share this article