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分光光度法和 HPLC 法测定马来酸罗格列酮和盐酸二甲双胍的抗糖尿病药物,在纯品和药物制剂中的含量。

Spectrophotometric and HPLC determinations of anti-diabetic drugs, rosiglitazone maleate and metformin hydrochloride, in pure form and in pharmaceutical preparations.

机构信息

Istanbul University, Faculty of Pharmacy, Department of Analytical Chemistry, 34116 Beyazit, Istanbul, Turkey.

出版信息

Eur J Med Chem. 2009 Dec;44(12):4998-5005. doi: 10.1016/j.ejmech.2009.09.003. Epub 2009 Sep 11.

DOI:10.1016/j.ejmech.2009.09.003
PMID:19781822
Abstract

In this study, three spectrophotometric methods and one HPLC method were developed for analysis of anti-diabetic drugs in tablets. The two spectrophotometric methods were based on the reaction of rosiglitazone (RSG) with 2,3-dichloro-5,6-dicyano-1,4-benzoquinone (DDQ) and bromocresol green (BCG). Linear relationship between the absorbance at lambda(max) and the drug concentration was found to be in the ranges 6.0-50.0 and 1.5-12 microg ml(-1) for DDQ and BCG methods, respectively. The third spectrophotometric method consists of a zero-crossing first-derivative spectrophotometric method for simultaneous analysis of RSG and metformin (MTF) in tablets. The calibration curves were linear within the concentration ranges of 5.0-50 microg ml(-1) for RSG and 1.0-10.0 microg ml(-1) for MTF. The fourth method is a rapid stability-indicating HPLC method developed for the determination of RSG. A linear response was observed within the concentration range of 0.25-2.5 microg ml(-1). The proposed methods have been successfully applied to the tablet analysis.

摘要

本研究建立了三种分光光度法和一种 HPLC 法用于分析片剂中的抗糖尿病药物。两种分光光度法基于罗格列酮(RSG)与 2,3-二氯-5,6-二氰基-1,4-苯醌(DDQ)和溴甲酚绿(BCG)的反应。DDQ 和 BCG 方法的吸光度与药物浓度之间的线性关系分别在 6.0-50.0 和 1.5-12μg/ml 范围内。第三种分光光度法是一种零交叉一阶导数分光光度法,用于同时分析片剂中的 RSG 和二甲双胍(MTF)。RSG 的校准曲线在 5.0-50μg/ml 范围内呈线性,MTF 的校准曲线在 1.0-10.0μg/ml 范围内呈线性。第四种方法是一种快速的用于测定 RSG 的稳定性指示 HPLC 方法。在 0.25-2.5μg/ml 的浓度范围内观察到线性响应。所提出的方法已成功应用于片剂分析。

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