Improving sensitivity in chiral supercritical fluid chromatography for analysis of active pharmaceutical ingredients.

摘要: Despite its status as the preferred method for routine enantiopurity analysis in pharmaceutical research, supercritical fluid chromatography (SFC) has historically been unsuited accurate and precise measurements required release testing of active ingredients (APIs) under current good manufacturing processes (cGMPs). Insufficient signal to noise, compared HPLC, heretofore major limitation chiral SFC approach. We herein describe an investigation into fundamental limitations sources noise approach, identifying thermal, electronic, mechanical within flow cell key parameters contributing reduced sensitivity. A variety instrument modifications are explored, ultimately leading development a new improved other that allow suitable sensitivity accuracy carry out GMP using SFC. Chirality, 2007. © 2007 Wiley-Liss, Inc.