Sensitive high-performance liquid chromatographic assay method for the determination of guggulsterone in serum

Guggulsterone (I) is a new hypolipidemic agent, being developed at CDRI (Lucknow, India). A sensitive high-performance liquid chromatographic assay in serum has been developed and validated for the determination of guggulsterone in serum for pharmacokinetic studies. This assay method consists of extraction of the drug with hexane from spiked human serum samples. Separation was achieved using C18 reversed-phase column coupled with photodiode array detector, and an acetonitrile-water mixture as mobile phase. The method described herein is simple and has limit of quantitation of 10 ng/ml as compared to 200 ng/ml by the previous reported method. The standard curve was linear over the range of 10-1000 ng/ml in mobile phase as well as in normal human serum. Analytical recovery of I added to serum was > 90%. The reproducibility was determined by the inter- and intra-assay variations which were < 10%.