A validated HPLC-DAD method quantifies psilocybin and psilocin in psychedelic mushroom extracts for medicinal use. Following Brazilian ANVISA guidelines, the method achieved detection limits of 1.58 mg/L for psilocybin and 1.70 mg/L for psilocin, with quantification limits of 4.78 and 5.17 mg/L, respectively. Recovery intervals ranged from 80–120% for psilocybin and 98–116% for psilocin. The mushroom samples contained 2.57% psilocybin and 0.16% psilocin. Accurate measurement of these compounds supports their reliable use in therapeutic contexts, emphasizing the need for precise quantification in developing safe medical treatments.
An active pharmaceutical ingredient (API) extracted from Psilocybe mushrooms yielded approximately 20% of target compounds, with psilocybin and psilocin contents of 3.26% and 0.34%, respectively. The API showed high purity, stability, solubility in polar solvents, low toxicity, and compliance with limits for heavy metals and microbes. It is compatible with polymeric matrices for controlled release. The work demonstrates the feasibility of a standardized psilocybin-based API for treating mental disorders.