Enhancement of teprenone isomer separation by subcritical fluid chromatography using porous graphitic carbon column

Abstract Teprenone is a therapeutic anti-ulcer agent developed in Japan. As described the Japanese Pharmacopoeia (JP) 17th Edition, gas chromatography/hydrogen flame ionization detection (GC/FID) and high-performance liquid chromatography/ultraviolet (HPLC/UV) have been used for assay of active pharmaceutical ingredients (APIs) teprenone capsules, respectively. The critical aspect separation structural isomers (mono-cis all-trans) teprenone. Herein, we propose an improved quantitative method quality control APIs capsules via subcritical fluid chromatography/photo diode array (SubFC/PDA) using porous graphitic carbon column. SubFC conditions, i.e., type content organic modifier mobile phase, column temperature, injection volume, flow rate, were optimized. SubFC/PDA was validated according to ICH guidelines Q2(R1) terms accuracy, precision (repeatability intermediate precision), specificity, linearity, quantification range, robustness, stability. Comparison with GC/FID or HPLC/UV (described JP) revealed that gave better resolution run time than JP methods. expected be useful analysis isomers.