Singh S K, Verma N, Gupta R C
Pharmacokinetic and Metabolism Division, Central Drug Research Institute, Lucknow, India.
J Chromatogr B Biomed Appl. 1995 Aug 4;670(1):173-6. doi: 10.1016/0378-4347(95)00149-d.
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%.
古古甾酮（I）是一种新型降血脂药物，由印度勒克瑙的中央药物研究所研发。已开发并验证了一种用于血清中药物动力学研究的灵敏高效液相色谱法，用于测定血清中的古古甾酮。该测定方法包括用己烷从加标的人血清样品中提取药物。使用C18反相柱与光电二极管阵列检测器联用，以乙腈 - 水混合物作为流动相进行分离。本文所述方法简单，定量限为10 ng/ml，而先前报道的方法为200 ng/ml。标准曲线在流动相以及正常人血清中的10 - 1000 ng/ml范围内呈线性。添加到血清中的I的分析回收率> 90%。通过批间和批内变异确定重现性，其< 10%。
