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高效液相色谱法测定药物溶液中痕量催产素

Determination of trace levels of oxytocin in pharmaceutical solutions by high-performance liquid chromatography.

作者信息

Brown D S, Jenke D R

机构信息

Travenol Laboratories, Inc., Morton Grove, IL 60053.

出版信息

J Chromatogr. 1987 Nov 20;410(1):157-68. doi: 10.1016/s0021-9673(00)90043-8.

DOI:10.1016/s0021-9673(00)90043-8
PMID:3429546
Abstract

A high-performance liquid chromatographic assay has been developed for quantitating oxytocin in common large volume parenteral intravenous solution matrices. Separation is accomplished by a reversed-phase mechanism using a C18 column. The analyte is detected fluorimetrically after post-column derivatization with fluorescamine. Reaction efficiency is controlled by the use of a reaction buffer which is added separately from the fluorescamine via a dual pump reactor system. Given the low analyte concentration [40 parts per billion (10(9)) or less], the samples are concentrated on-line through the use of a trapping column and switching valve. To improve productivity, pre-concentration and analysis of adjacent samples is timed to occur concurrently. Performance of the assay is characterized by a high degree of accuracy, precision and ruggedness; the system is capable of distinguishing between the analyte, matrix components, impurities and common degradates.

摘要

已开发出一种高效液相色谱分析法,用于定量常见大容量肠胃外静脉输液基质中的催产素。采用C18柱通过反相机制实现分离。分析物在与荧光胺进行柱后衍生化后通过荧光法进行检测。反应效率通过使用反应缓冲液来控制,该缓冲液通过双泵反应器系统与荧光胺分开添加。鉴于分析物浓度较低[十亿分之40(10⁹)或更低],样品通过使用捕集柱和切换阀进行在线浓缩。为提高生产率,相邻样品的预浓缩和分析安排为同时进行。该分析方法的性能具有高度的准确性、精密度和耐用性;该系统能够区分分析物、基质成分、杂质和常见降解产物。

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