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吩噻嗪原料药及制剂中砜杂质的二阶导数荧光光谱法测定

Second-derivative spectrofluorometric determination of sulphoxide impurity in phenothiazine drug substances and formulation.

作者信息

Davidson A G, Fadiran E O

机构信息

Department of Pharmacy, University of Strathclyde, Glasgow, UK.

出版信息

Analyst. 1990 Jul;115(7):997-1001. doi: 10.1039/an9901500997.

DOI:10.1039/an9901500997
PMID:2221404
Abstract

A direct second-derivative spectrofluorimetric procedure for determining sulphoxide impurity in phenothiazines and their formulations has been developed. The method, which has been applied to the analysis of chlorpromazine hydrochloride and prochlorperazine mesylate, as examples of typical phenothiazine substances, and to their formulations, is based on the measurement of the amplitude taken from the minimum at ca. 270 nm to the longer wavelength maximum in the second-derivative excitation spectrum of the sulphoxide in pH 8 buffer solution. The method is rapid, accurate and precise, and can be used to measure the concentration of sulphoxide in phenothiazines and their formulations at concentrations down to 0.1% m/m of that of the parent phenothiazine.

摘要

已开发出一种直接二阶导数荧光分光光度法,用于测定吩噻嗪及其制剂中的亚砜杂质。该方法已应用于典型吩噻嗪类物质盐酸氯丙嗪和甲磺酸丙氯拉嗪及其制剂的分析,它基于在pH 8缓冲溶液中,测量亚砜二阶导数激发光谱中约270 nm处最小值到较长波长最大值之间的振幅。该方法快速、准确且精密,可用于测定吩噻嗪及其制剂中亚砜的浓度,低至母体吩噻嗪浓度的0.1% m/m。

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