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在存在甲硝呋腙生产及降解杂质的情况下,采用高效薄层层析法和高效液相色谱法测定甲硝呋腙。

HPTLC and HPLC determination of isometamidium in the presence of its manufacturing and degradation impurities.

作者信息

Tettey J N, Skellern G G, Midgley J M, Grant M H

机构信息

Department of Pharmaceutical Sciences, University of Strathclyde, Glasgow, UK.

出版信息

J Pharm Biomed Anal. 1998 Aug;17(4-5):713-8. doi: 10.1016/s0731-7085(98)00008-9.

DOI:10.1016/s0731-7085(98)00008-9
PMID:9682154
Abstract

The determination of the phenanthridine trypanocide, isometamidium chloride hydrochloride (ISM), in the presence of four process-related and degradation impurities, by RP-HPLC using a Licrospher-60 RP-select B column with a mobile phase composition of acetonitrile/KH2PO4 (PH 3.0, 20 mM) (25:75 v/v) with UV detection at 320 nm, is described. The method is selective, reproducible and precise with a limit of detection of 45 ng ml-1 for ISM. A HPTLC system (Kieselgel 60 F254, pyridine/acetonitrile/butanol/formic acid, 6:6:4:1, v/v), with UV densitometric evaluation at 320 nm, suitable for the separation of ISM and the related substances is reported.

摘要

描述了使用Licrospher - 60 RP - select B柱,流动相组成为乙腈/KH₂PO₄(pH 3.0,20 mM)(25:75 v/v),在320 nm处进行紫外检测的反相高效液相色谱法,用于在四种工艺相关杂质和降解杂质存在的情况下测定菲啶类杀锥虫药盐酸异美汀(ISM)。该方法具有选择性、可重复性和精确性,ISM的检测限为45 ng/ml⁻¹。报道了一种高效薄层色谱系统(硅胶60 F254,吡啶/乙腈/丁醇/甲酸,6:6:4:1,v/v),在320 nm处进行紫外光密度测定,适用于ISM及其相关物质的分离。

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