SENSITIVE HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHIC ASSAY-METHOD FOR THE DETERMINATION OF GUGGULSTERONE IN SERUM

Guggulsterone (I) is a new hypolipidemic agent, being developed at CDR I (Lucknow, India). A sensitive high-performance liquid chromatographi c assay in serum has been developed and validated for the determinatio n of guggulsterone in serum for pharmacokinetic studies. This assay me thod consists of extraction of the drug with hexane from spiked human serum samples. Separation was achieved using C-18 reversed-phase colum n coupled with photodiode array detector, and an acetonitrile-water mi xture as mobile phase. The method described herein is simple and has l imit of quantitation of 10 ng/ml as compared to 200 ng/ml by the previ ous reported method. The standard curve was linear over the range of 1 0-1000 ng/ml in mobile phase as well as in normal human serum. Analyti cal recovery of I added to serum was >90%. The reproducibility was det ermined by the inter- and intra-assay variations which were <10%.