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一阶和二阶导数同步荧光法及分光光度法同时测定盐酸非索非那定及其降解产物。应用于稳定性研究。

First and second derivative synchronous fluorescence and spectrophotometric spectroscopy for the simultaneous determination of fexofenadine hydrochloride in presence of its degradation products. Application to stability studies.

作者信息

El-Din Mohie Khaled Sharaf, Ibrahim Fawzia Ahmed, Eid Manal Ibrahim, Wahba Mary Elias Kamel

出版信息

Acta Chim Slov. 2011 Jun;58(2):278-87.

Abstract

Two rapid, simple, sensitive, selective and economic derivative spectrophotometric (first [D1] and second [D2]) and synchronous spectrofluorimetric (FDSFS and SDSFS) methods have been developed for the analysis of fexofenadine hydrochloride (FXD) in the presence of its different degradation products. Derivative spectrophotometry (D1) was used to measure FXD at 223 nm in the presence of its alkaline or acidic degradation products, and at 211 nm in the presence of its oxidative degradation product. Derivative spectrophotometry (D2) was used to determine FXD at 217 nm in the presence of its alkaline or acidic degradation products, and at 215 nm in the presence of its oxidative degradation product; the UV degradation product was measured at 211 nm. Synchronous spectrofluorimetry (FDSFS) was used to measure FXD in the presence of its alkaline or acidic degradation products at 406 nm, and at 367 nm in the presence of its oxidative or UV degradation products. Synchronous spectrofluorimetry (SDSFS) was applied to determine the drug at 225 nm in the presence of its alkaline, acidic, oxidative or UV degradation products. The proposed methods were successfully applied for the determination of the studied compound in its commercial tablets. The results obtained were in good agreement with those obtained by the comparison method.

摘要

已开发出两种快速、简便、灵敏、选择性好且经济的导数分光光度法(一阶导数[D1]和二阶导数[D2])以及同步荧光分光光度法(固定波长同步荧光法和可变波长同步荧光法),用于在存在不同降解产物的情况下分析盐酸非索非那定(FXD)。导数分光光度法(D1)用于在存在碱性或酸性降解产物时于223nm处测定FXD,在存在氧化降解产物时于211nm处测定。导数分光光度法(D2)用于在存在碱性或酸性降解产物时于217nm处测定FXD,在存在氧化降解产物时于215nm处测定;紫外降解产物在211nm处测定。同步荧光分光光度法(固定波长同步荧光法)用于在存在碱性或酸性降解产物时于406nm处测定FXD,在存在氧化或紫外降解产物时于367nm处测定。同步荧光分光光度法(可变波长同步荧光法)用于在存在碱性、酸性、氧化或紫外降解产物时于225nm处测定该药物。所提出的方法已成功应用于测定其市售片剂中的研究化合物。所得结果与通过比较法获得的结果高度一致。

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