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Nutraceuticals are referred to as phytochemicals or functional foods. They are natural bioactive chemical compounds which possess health promoting, disease preventing or medicinal properties. Because these agents have important biological properties they have fallen under the regulatory control of the Food and Drug Administration. The FDA is granted the authority to promulgate current Good Manufacturing Practice (cGMP) for dietary supplements. Specifications must be set and met for limits on contaminants such as heavy metals, solvent residues and microorganisms in finished products. Many of the nutraceutical products are of herbal origin, and their active chemical properties are based on plant alkaloids

As part of the new FDA legislation there is an entire subpart devoted to requirements for the operation of an analytical laboratory. The laboratory facilities must be adequate to perform whatever tests and examinations are necessary to determine if specifications are met for raw materials, materials in progress and finished goods. Thin layer chromatography (TLC) is an excellent means for the qualitative identification of herbals and for purity evaluations. Given that fact that most botanical agents are plant alkaloids TLC plants coated with alumina have become the preferred screening tool of choice, as botanicals have species specific fingerprints. HPLC is an excellent tool for the quantitative analysis of marker compounds in botanical samples. Selecting a desired phytochemical is an appropriate method of establishing a quantitative analysis for a marker compound. Gas chromatography may be useful for the analysis of volatile marker compounds and residual solvents.

HPLC is the most efficient method for the qualitative and quantitative analysis of many botanical agents, allowing great sensitivity, resolution, reproducibility and speed of analysis under inert conditions. The potency of this technique has been improved by the introduction of new detectors such as diode array detectors allowing detection at several wavelengths and simultaneous identification by UV spectral analysis as well as mass and nuclear magnetic resonance detectors. The reader is referred to the Primer on Column Chromatography available from Dynamic Adsorbents for further discussion regarding the use of HPLC techniques for nutraceutical purification.

More Careful Scrutiny Encouraged for Purification and Quantitative Testing of Nutritional Supplements – Recent case of selenium toxicity points to need for FDA to toughen regulations for supplements | Role of Chromatography in the Purification of Nutraceutical New FDA Guidelines Mandate Highlights Importance of this Essential Analytical Technique