Application of quinone-based fluorophore and native fluorescence for the spectrofluorimetric determination of agomelatine in dosage form

Identification of acidic and alkaline- induced degradation products by LC–MS/TOF

Fawzia Ibrahim, Asmaa Kamal El-Deen, Kuniyoshi Shimizu

研究成果: ジャーナルへの寄稿記事

1 引用 (Scopus)

抄録

Three spectrofluorimetric methods were developed for agomelatine (AGM) determination in commercial tablets. Method A is based on measuring the native fluorescence of AGM aqueous solution at 230/360 nm. Methods B and C are based on the formation of a charge transfer complex between AGM and 2,3-dichloro-5,6-dicyano-1,4-benzoquinone (DDQ) and 7,7,8,8-tetracyanoquinodimethane (TCNQ) with measurement of the formed fluorophore at 365/475 nm and 250/304 nm, respectively. The relative fluorescence intensity (RFI) of AGM–DDQ complex was greatly enhanced in the presence of methyl-β-cyclodextrin (CD). The methods were linear over the concentration ranges of 0.015–0.5, 0.5–8.0, 0.09–6.0 and 0.05–0.2 μg/ml for AGM-native fluorescence, AGM–DDQ, AGM–DDQ–CD and AGM–TCNQ complexes, respectively with excellent correlation coefficients (r = 0.9999). The methods were validated as per the International Conference on Harmonization (ICH) guidelines and all validation requirements were satisfied. The developed methods were extended to the analysis of AGM in commercial tablets. Furthermore, the stability of AGM was studied under different stress conditions (alkaline, acidic, oxidative and photolytic). The potential alkaline and acidic degradation products were identified by LC–MS/TOF.

元の言語英語
ページ(範囲)225-231
ページ数7
ジャーナルLuminescence
33
発行部数1
DOI
出版物ステータス出版済み - 2 1 2018

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S 20098
Fluorophores
Dosage Forms
Fluorescence
Degradation
Tablets
Cyclodextrins
benzoquinone
Charge transfer
Guidelines

All Science Journal Classification (ASJC) codes

  • Biophysics
  • Chemistry (miscellaneous)

これを引用

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title = "Application of quinone-based fluorophore and native fluorescence for the spectrofluorimetric determination of agomelatine in dosage form: Identification of acidic and alkaline- induced degradation products by LC–MS/TOF",
abstract = "Three spectrofluorimetric methods were developed for agomelatine (AGM) determination in commercial tablets. Method A is based on measuring the native fluorescence of AGM aqueous solution at 230/360 nm. Methods B and C are based on the formation of a charge transfer complex between AGM and 2,3-dichloro-5,6-dicyano-1,4-benzoquinone (DDQ) and 7,7,8,8-tetracyanoquinodimethane (TCNQ) with measurement of the formed fluorophore at 365/475 nm and 250/304 nm, respectively. The relative fluorescence intensity (RFI) of AGM–DDQ complex was greatly enhanced in the presence of methyl-β-cyclodextrin (CD). The methods were linear over the concentration ranges of 0.015–0.5, 0.5–8.0, 0.09–6.0 and 0.05–0.2 μg/ml for AGM-native fluorescence, AGM–DDQ, AGM–DDQ–CD and AGM–TCNQ complexes, respectively with excellent correlation coefficients (r = 0.9999). The methods were validated as per the International Conference on Harmonization (ICH) guidelines and all validation requirements were satisfied. The developed methods were extended to the analysis of AGM in commercial tablets. Furthermore, the stability of AGM was studied under different stress conditions (alkaline, acidic, oxidative and photolytic). The potential alkaline and acidic degradation products were identified by LC–MS/TOF.",
author = "Fawzia Ibrahim and El-Deen, {Asmaa Kamal} and Kuniyoshi Shimizu",
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T1 - Application of quinone-based fluorophore and native fluorescence for the spectrofluorimetric determination of agomelatine in dosage form

T2 - Identification of acidic and alkaline- induced degradation products by LC–MS/TOF

AU - Ibrahim, Fawzia

AU - El-Deen, Asmaa Kamal

AU - Shimizu, Kuniyoshi

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N2 - Three spectrofluorimetric methods were developed for agomelatine (AGM) determination in commercial tablets. Method A is based on measuring the native fluorescence of AGM aqueous solution at 230/360 nm. Methods B and C are based on the formation of a charge transfer complex between AGM and 2,3-dichloro-5,6-dicyano-1,4-benzoquinone (DDQ) and 7,7,8,8-tetracyanoquinodimethane (TCNQ) with measurement of the formed fluorophore at 365/475 nm and 250/304 nm, respectively. The relative fluorescence intensity (RFI) of AGM–DDQ complex was greatly enhanced in the presence of methyl-β-cyclodextrin (CD). The methods were linear over the concentration ranges of 0.015–0.5, 0.5–8.0, 0.09–6.0 and 0.05–0.2 μg/ml for AGM-native fluorescence, AGM–DDQ, AGM–DDQ–CD and AGM–TCNQ complexes, respectively with excellent correlation coefficients (r = 0.9999). The methods were validated as per the International Conference on Harmonization (ICH) guidelines and all validation requirements were satisfied. The developed methods were extended to the analysis of AGM in commercial tablets. Furthermore, the stability of AGM was studied under different stress conditions (alkaline, acidic, oxidative and photolytic). The potential alkaline and acidic degradation products were identified by LC–MS/TOF.

AB - Three spectrofluorimetric methods were developed for agomelatine (AGM) determination in commercial tablets. Method A is based on measuring the native fluorescence of AGM aqueous solution at 230/360 nm. Methods B and C are based on the formation of a charge transfer complex between AGM and 2,3-dichloro-5,6-dicyano-1,4-benzoquinone (DDQ) and 7,7,8,8-tetracyanoquinodimethane (TCNQ) with measurement of the formed fluorophore at 365/475 nm and 250/304 nm, respectively. The relative fluorescence intensity (RFI) of AGM–DDQ complex was greatly enhanced in the presence of methyl-β-cyclodextrin (CD). The methods were linear over the concentration ranges of 0.015–0.5, 0.5–8.0, 0.09–6.0 and 0.05–0.2 μg/ml for AGM-native fluorescence, AGM–DDQ, AGM–DDQ–CD and AGM–TCNQ complexes, respectively with excellent correlation coefficients (r = 0.9999). The methods were validated as per the International Conference on Harmonization (ICH) guidelines and all validation requirements were satisfied. The developed methods were extended to the analysis of AGM in commercial tablets. Furthermore, the stability of AGM was studied under different stress conditions (alkaline, acidic, oxidative and photolytic). The potential alkaline and acidic degradation products were identified by LC–MS/TOF.

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