Use of Fingerprinting and Marker Compounds for Identification and Standardization of Botanical Drugs: Strategies for App
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Use of Fingerprinting and Marker Compounds for Identification and Standardization of Botanical Drugs: Strategies for Applying Pharmaceutical HPLC Analysis to Herbal Products Natalie J. Lazarowych and Peter Pekos Drug Information Journal 1998 32: 497 DOI: 10.1177/009286159803200222 The online version of this article can be found at: http://dij.sagepub.com/content/32/2/497
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Drug Infomation Journal. VOl. 32. pp. 497-512, 1998 Rinted in the USA. All rights reserved.
0092-86L5198 Copyright 0 1998 Drug Information Association Inc.
USE OF FINGERPRINTING AND MARKER COMPOUNDS FOR IDENTIFICATION AND STANDARDIZATION OF BOTANICAL DRUGS: STRATEGIES FOR APPLYING PHARMACEUTICAL HPLC ANALYSIS TO HERBAL PRODUCTS NATALIEJ. LAZAROWYCH, PHD Director of Research, Ashbury Biologicals Inc., Toronto, Canada
PETERPEKOS,MSc Vice President, Ashbury Biologicals Inc.. Toronto, Canada
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 f o r raw materials, standardize botanical preparations during all aspects of manufacturing processes, and obtain stability profiles. HPLC analysisfor marker compounds may provide additional information in the form of “chromatographic fingerprints.” Examples discussed include valerian (Valeriana oficinalis) 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. Key Words: Fingerprinting; HPLC; Marker; Botanical; Herbal
INTRODUCTION
lated herbal product. In this framework, botanical products contrast to single chemical ASHBURY BIOLOGICALS INC.’S ap- entities. There are difficulties inherent in tryproach has been to treat herbals like single ing to apply pharmaceutical current Good chemical entity pharmaceuticals in every Manufacturing Practices (cGMP) to botaniway possible. The drug substance is the plant cal products. There is variability within the or extract and the drug product is the formu- same plant materials. This variability may be from grower to grower and crop to crop, and
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