Protocols and Tools for Transferring USP Methods to Modern UPLC Technology

来源 :第2届大连国际色谱学术报告会、第37届国际高效液相色谱及相关技术会议、第18届全国色谱学术报告会 | 被引量 : 0次 | 上传用户:Q672855312
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  Established methods for the measurement of components of drug substances and drug products are provided in national and regional pharmacopeial compendia.The details of these methods reflect their original development on the chromatographic instrumentation and column chemistry in common use in the past.Modern instruments and separation chemistries provide more robust routine operation with more stable performance over the method life cycle.With increasing acceptance of UltraPerfomance Liquid Chromatography (UPLC) techniques, method transfer has become particularly desirable.By using columns packed with sub-2 m particles on instruments optimized to preserve the reduced band-broadening, separations are characterized by improved resolution and better sensitivity, typically in a shorter run time with higher throughput.The utility of applying this technology to compendial methods is clear, but the transfer must follow accepted guidelines and must yield the same analytical result.We have investigated a systematic protocol for transferring USP methods to UPLC and developed a set of tools to streamline the process.
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