Determination of hexane impurities in eye drops solutions utilizing HS-GC/FID

摘要

The potential deleterious effects of extractables/leachables in pharmaceutical products led the USP, EP and JP to require extractable and toxicity testing of container/closure systems. To that, a HS-GC/FID method was developed and validated for the determination of hexane as potential extractable residue from pharmaceutical container closure system into eye drops solutions. A migration study was further applied in eight eye drops formulations currently marketed products after short and long term exposure of these products at various temperatures. This method allows the establishment of hexane safety qualification thresholds to monitor eye drops solutions products for this residue.