Abstract
For standardization of natural product drugs, single chemical entities, “marker compounds,” may be used as potency standards in high performance liquid chromatography (HPLC) analysis. Using well-characterized marker compounds, conventional pharmaceutical manufacturing criteria for assay and content uniformity may be applied. These marker compounds may be used to help identify herbal materials, set specifications for raw materials, standardize botanical preparations during all aspects of manufacturing processes, and obtain stability profiles. HPLC analysis for marker compounds may provide additional information in the form of “chromatographic fingerprints.” Examples discussed include valerian (Valeriana officinalis) and feverfew (Tanacetum parthenium). The benefits and limitations of using markers are discussed. An intent of this paper is to illustrate how, in certain instances, chromatographic fingerprinting and markers can by used to make consistent herbal drug products.
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