High-performance liquid chromatographic method for fingerprinting and quantitative determination of E- and Z-guggulsterones in Commiphora mukul resinand its products

A high-performance liquid chromatographic method has been developed and val idated for the fingerprinting (profiling) and quantitative determination of E- and Z-guggulsterones, the hypolipidemic agents in the gum-resin exudate of Commiphora mukul, currently marketed worldwide as hypocholesterolemic. The method involves extraction of the guggul-resin from either the raw exud ate or compounded tablets (or capsules) with ethyl acetate, concentration o f the combined extracts and chromatography on a reversed-phase C-18 column using an acetonitrile-water gradient. The method has a validated quantitati on range of 15-85 mu g/ml for E-guggulsterone and 25-130 mu g/ml for Z-gugg ulsterone with a precision of +/-2% S.D. and a recovery of >99.5%. Standard curve correlation coefficients of 0.992 or greater were obtained during va lidation experiments. The method was applied to six commercial (OTC) produc ts, all of which were found to contain significantly less (in most cases ve ry little or none) of the claimed guggulsterones. (C) 1998 Elsevier Science B.V. All rights reserved.