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离子对色谱法测定注射剂中的乙二胺四乙酸

Determination of ethylenediamine tetraacetic acid in injection forms by ion-pair chromatography.

作者信息

Pistos C, Parissi-Poulou M

机构信息

Division of Pharmaceutical Chemistry, School of Pharmacy, University of Athens, Panepistimiopolis Zografou, Athens, Greece.

出版信息

J Pharm Biomed Anal. 2002 Jun 15;28(6):1073-9. doi: 10.1016/s0731-7085(02)00049-3.

Abstract

A high performance liquid chromatographic method was developed for the determination of ethylenediamine tetraacetic acid (EDTA) in injection forms. The method consists of direct extraction of the samples with ethyl acetate; the organic layers were evaporated to dryness and further diluted to a 0.025% (w/v) copper nitrate in order to achive the formation of the EDTA-copper solution complex. The chromatographic separation was performed on a C8 Hypersil column. The mobile phase consisted of a mixture of acetonitrile-0.015 M tetrabutylammonium hydroxide (10:90, v/v), (pH* 7.0) pumped at a flow rate of 1.5 ml min(-1). The UV detector was operated at 300 nm. Correlation coefficients of the calibration graphs were better than 0.9995, relative standard deviation was less than 2.5%. Detection limit of EDTA was found to be 1.97 microg ml(-1).

摘要

建立了一种高效液相色谱法用于测定注射剂形式的乙二胺四乙酸(EDTA)。该方法包括用乙酸乙酯直接萃取样品;将有机层蒸发至干,再用0.025%(w/v)硝酸铜进一步稀释,以形成EDTA-铜溶液络合物。色谱分离在C8 Hypersil柱上进行。流动相由乙腈-0.015 M氢氧化四丁铵(10:90,v/v)的混合物组成,(pH 7.0),流速为1.5 ml min(-1)。紫外检测器在300 nm波长下运行。校准曲线的相关系数优于0.9995,相对标准偏差小于2.5%。EDTA的检测限为1.97 μg ml(-1)。

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