Direct Method Scaiim from UHPLC to HPLC: Isthis feasible for Pharmaceutical Methods?

摘要

The use of UHPLC is getting a lot of attention these days for moving pharmaceutical and environmental chromatographic applications to improved capabilities in selectivity and detection. Yet, UHPLC has one fundamental flaw in the eyes of many lab managers - it requires new capital outlays to buy instrumentation capable of running at the required higher pressures (up to 15,000 psi). UHPLC requires a chromatographic system that can operate at high pressures. Its current challenge is that not every lab has one. Often, if the lab does have one, it has not been properly qualified for GMP use. Pharmaceutical companies across the industry are challenged by labs that are developing UHPLC methods and cannot directly transfer these methods to receiving labs unless they too have a qualified UHPLC. In addition, not all UHPLC instruments perform to the same specifications, making transfer even more difficult as vendor-specific limitations can potentially cripple an analytical transfer.Scaling methods from traditional LC to UHPLC has been the focus of many laboratories in recent years. Now, a new spin on the transfer has developed; can you transfer back from UHPLC to traditional LC systems? The potential to transfer UHPLC methods back to traditional LC platforms has two significant advantages: (1) it directly addresses the limitations in analytical method transfers in the pharmaceutical industry and (2) with the advent of quality by design (QbD) robustness studies, many labs are looking to run these lengthy investigations using fast UHPLC methods and then apply these robustness conclusions back to "transferable" LC methods. The feasibility of transferring from UHPLC back to traditional LC methods will be discussed.