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反相/阳离子交换/阴离子交换三模态固定相的比较及其在活性药物成分和抗衡离子测定中的应用。

Comparison of reversed-phase/cation-exchange/anion-exchange trimodal stationary phases and their use in active pharmaceutical ingredient and counterion determinations.

机构信息

Thermo Fisher Scientific, 1228 Titan Way, Sunnyvale, CA 94088, USA.

出版信息

J Chromatogr A. 2012 Apr 6;1232:190-5. doi: 10.1016/j.chroma.2011.12.009. Epub 2011 Dec 9.

DOI:10.1016/j.chroma.2011.12.009
PMID:22209548
Abstract

This study involved three commercial reversed-phase (RP)/anion-exchange (AEX)/cation-exchange (CEX) trimodal columns, namely Acclaim Trinity P1 (Thermo Fisher Scientific), Obelisc R (SIELC Technologies) and Scherzo SM-C18 (Imtakt). Their chromatographic properties were compared in details with respect to hydrophobicity, anion-exchange capacity, cation-exchange capacity, and selectivity, by studying retention behavior dependency on organic solvent, buffer concentration and pH. It was found that their remarkably different column chemistries resulted in distinctive chromatography properties. Trinity P1 exhibited strong anion-exchange and cation-exchange interactions but low RP retention while Scherzo SM-C18 showed strong reversed-phase retention with little cation-exchange and anion-exchange capacities. For Obelisc R, its reversed-phase capacity was weaker than Scherzo SM-C18 but slightly higher than Trinity P1, and its ion-exchange retentions were between Trinity P1 and Scherzo SM-C18. In addition, their difference in selectivity was demonstrated by examples of determining the active pharmaceutical ingredient (API) and counterion of drug products.

摘要

本研究涉及三种商业反相(RP)/阴离子交换(AEX)/阳离子交换(CEX)三模态柱,即 Acclaim Trinity P1(赛默飞世尔科技)、Obelisc R(SIELC Technologies)和 Scherzo SM-C18(Imtakt)。通过研究保留行为对有机溶剂、缓冲液浓度和 pH 的依赖性,详细比较了它们在疏水性、阴离子交换容量、阳离子交换容量和选择性方面的色谱性能。结果发现,它们显著不同的柱化学性质导致了独特的色谱性质。Trinity P1 表现出强烈的阴离子交换和阳离子交换相互作用,但 RP 保留性低,而 Scherzo SM-C18 表现出强反相保留性,阳离子交换和阴离子交换容量较小。对于 Obelisc R,其反相容量弱于 Scherzo SM-C18,但略高于 Trinity P1,其离子交换保留介于 Trinity P1 和 Scherzo SM-C18 之间。此外,通过测定药物产品的活性药物成分(API)和反离子的实例,证明了它们在选择性方面的差异。

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