ANALYSIS AND STABILITY OF A NOVEL ANTICANCER AGENT, SJ-8029, POSSESSING MICROTUBULE AND TOPOISOMERASE INHIBITING ACTIVITIES

ABSTRACT This report describes a simple and sensitive isocratic high-performance liquid chromatography with UV detection for the analysis of a novel antineoplastic agent, SJ-8029 in rat serum. The analysis utilized a Merck Lichrocart RP-8 analytical column and a mobile phase consisting of acetonitrile: 0.1% triethylamine in deionized water (55 : 45, v/v). SJ-8029 was extracted from serum by one-step extraction with tert-butyl methyl ether. SJ-8029 was eluted at 12.7 min at a mobile phase flow rate of 1 mL/min. The standard curve was linear (r 2 = 0.9999) over the concentration range of 5–10,000 ng/mL. The extraction recovery for SJ-8029 was >89.4% and the intra- and inter-day assay variability of SJ-8029 ranged from 3.9–18.8% and 4.5–18.4%, respectively. The LOD and LOQ were 1 and 5 ng/mL, respectively, using a serum sample volume of 100 µL. The developed assay method was applied to a pharmacokinetic study after i.v. injection of SJ-8029 to rats at a dose of 8 mg/kg. In addition, the stability of SJ-8029 ...