Assessment of volatile component stability in Guanxin Jieyu granules through gas chromatography in accordance with Q14 guidelines

Abstract

Abstract Guanxin Jieyu Granules, a novel traditional Chinese medicine (TCM) in development, targets stable angina pectoris with accompanying anxiety. To improve stability, its volatile oil components—including borneol—are stabilized via β-cyclodextrin inclusion. In compliance with ICH Q14 guidelines, a gas chromatography (GC) analytical method was developed, incorporating knowledge management, risk management, experimental design, and results analysis, as well as performance evaluation of the analytical method. Accelerated Destructive Degradation Tests (ADDTs) using this method revealed a dramatic stability enhancement from β-cyclodextrin encapsulation. At 25 °C over 730 days, the inclusion complex showed only a 1.10% probability of failure (defined as ≥ 5% content loss), compared to 88.50% for the physical mixture. These results underscore the critical role of cyclodextrin inclusion in preserving volatile TCM constituents.