Analysis of Azido Impurities using the Avantor® ACE® C18 -PFP

Avantor® ACE® C18 -PFP 컬럼을 이용한 사르탄계 의약품 내 아지드 불순물 분석

Recent regulatory investigations have identified potentially mutagenic azido impurities in several sartan-containing pharmaceutical products, increasing the need for reliable analytical methods capable of detecting these compounds at trace levels. Impurities such as AZBT, AZLS, and AZBX have drawn particular attention because of their potential impact on drug safety and regulatory compliance. This application note describes an LC-MS/MS method for the selective determination of three azido impurities using the Avantor® ACE® Excel 3 C18-PFP column. By combining the hydrophobic retention of a C18 stationary phase with the enhanced shape selectivity, π-π interactions, and dipole-dipole interactions provided by pentafluorophenyl (PFP) functionality, the method delivers effective chromatographic separation and sensitive detection of structurally related compounds. Gradient elution coupled with multiple reaction monitoring (MRM) enables rapid, reproducible analysis. The results demonstrate that the ACE C18-PFP column provides excellent selectivity and chromatographic performance for azido impurity monitoring, support ing pharmaceutical quality control and regulatory compliance in the analysis of sartan-based drug products.