A UPLC- MS/MS Method to Quantify β-Sitosterol and Ferulic Acid of Pygeum Africanum Extract in Bulk and Pharmaceutical Preparation.

This article focuses on the development and validation of a liquid chromatography-electrospray ionization–tandem mass spectrometry (LC-ESI-MS/MS) method for quantifying β-Sitosterol and Ferulic acid, two primary bioactive compounds in Pygeum africanum extract, which is used in pharmaceutical products for benign prostatic hypertrophy (BPH) treatment. The method employs multiple reaction monitoring (MRM) for sensitive and specific detection, with validation performed according to U.S. Food and Drug Administration guidelines, demonstrating high accuracy, precision, and low detection limits. The study successfully applied this method to analyze commercial Pygeum capsule products, revealing that β-Sitosterol content decreases in expired batches while Ferulic acid levels remain stable. This validated approach offers a streamlined tool for rapid and reliable quantification of these compounds in pharmaceutical formulations containing Pygeum africanum.