Journal of Chromatographic Science · 2008 · 28 citations · 30 references
PharmacyPharmaceutical AnalysisToxicologyAnalytical ToxicologyFood ToxicologyNutritional ToxicologyBioanalytical Method ValidationDietary Supplement RegulationDietary Supplement ToxicityDrug Safety MonitoringRegulatory PharmacologyCaffeine ToxicityHerbal ToxicityPhotodiode ArraysPlant AlkaloidsToxic Dose AssessmentToxic Dose EstimationWeight Loss DrugWeight Loss Supplement Toxicity
Reversed-phase high-performance liquid chromatography utilizing photodiode array detection is used for the simultaneous determination of caffeine and nine alkaloids from Citrus aurantium (CA) and ephedra (EA) contained in dietary weight loss products. Since the Food and Drug Administration (FDA) ban of EA, manufacturers have substituted CA in their weight loss formulations, usually combined with high levels of caffeine. The alkaloids contained in CA have some physiological effects similar to those of the EA alkaloids and are, therefore, cause for concern. Caffeine has been shown to potentiate the toxicity of the EA alkaloids. Recently, a federal judge overturned the absolute ban and allowed marketing of low levels (<10 mg/day) of total EA alkaloids. To support an absolute ban, the FDA is now compelled to perform dose-dependent toxicology studies to determine the toxic dose(s) of EA. The toxicity of the CA compounds is largely unknown, especially in combination with caffeine. The described method enables quantitation over a wide range of product formulations. Recoveries range from 91% to 100% from a variety of fortified plant matrices.
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The Relative Safety of Ephedra Compared with Other Herbal Products
Stephen Bent, Thomas N. Tiedt, Michelle C. Odden et al. · Annals of Internal Medicine · 2003 · 165 citations