Determination of alcohols in pharmaceuticals by ion-exclusion chromatography.
Alcohols present in pharmaceutical intravenous solutions (e.g. propylene glycol and ethanol) are separated from each other and common matrix components by an ion-exclusion column with a dilute sulfuric acid mobile phase. Using refractive index detection, the assay is characterized by an absolute detection limit of 1 ng and a linear dynamic range for both area and height which spans three orders of magnitude. Chromatographic ruggedness is sufficiently high so that strict system suitability criteria can be met even after 600 injections have been made. Long-term detector stability is enhanced through the use of a flowing reference cell.
D000438:Alcohols / Q000032:analysis*; D002850:Chromatography, Gel; D004355:Drug Stability; D007202:Indicators and Reagents; D004364:Pharmaceutical Preparations / Q000032:analysis*
D000438:Alcohols; D007202:Indicators and Reagents; D004364:Pharmaceutical Preparations