Development of Green HPTLC method for simultaneous determination of a promising combination Tamsulosin and Mirabegron: stability-indicating assay was examined

Abstract Recently, mirabegron has been added to tamsulosin to treat overactive bladder in men with benign prostatic hypertrophy. A Rapid, selective, sensitive, and green high-performance thin-layer chromatography (HPTLC) approach was developed for the simultaneous determination of tamsulosin (TAM) a...

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Main Authors: Maha M. Abou El-Alamin, Safaa S. Toubar, Dina A. Mohamed, Marwa I. Helmy
Format: Article
Language:English
Published: BMC 2023-09-01
Series:BMC Chemistry
Subjects:
Online Access:https://doi.org/10.1186/s13065-023-01043-9
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author Maha M. Abou El-Alamin
Safaa S. Toubar
Dina A. Mohamed
Marwa I. Helmy
author_facet Maha M. Abou El-Alamin
Safaa S. Toubar
Dina A. Mohamed
Marwa I. Helmy
author_sort Maha M. Abou El-Alamin
collection DOAJ
description Abstract Recently, mirabegron has been added to tamsulosin to treat overactive bladder in men with benign prostatic hypertrophy. A Rapid, selective, sensitive, and green high-performance thin-layer chromatography (HPTLC) approach was developed for the simultaneous determination of tamsulosin (TAM) and mirabegron (MIR) in pure and laboratory-prepared mixture. Complete separation was obtained on silica gel F254 using the solvent system methanol-ethyl acetate-ammonia (3:7:0.1, v/v). Short-wave ultraviolet light at 270 nm was used to view the chromatographic bands. For MIR and TAM, the suggested technique revealed compact spots with retention factor Rf values of 0.42 and 0.63, respectively. Within concentration ranges of 0.15–7.5 µg/band and 0.05–2.5 µg/band, good linearity was observed, with mean percentage recoveries of 100.04 ± 0.56 and 99.98% ± 0.95 for MIR and TAM, respectively. Green assessment of the developed HPTLC technique was estimated using different green analytical chemistry metrics such as Analytical eco-scale Analytical GREEness (AGREE), and Green Analytical Procedure Index (GAPI) metrics. The proposed method was effectively used as a stability-indicating assay to assess the presence of MIR and TAM in the pharmaceutical dosage form in the presence of their degradation product. The statistical analysis showed high precision and accuracy.
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spelling doaj.art-fe9392aa7151444192e6058de730218f2023-11-19T12:15:33ZengBMCBMC Chemistry2661-801X2023-09-0117111810.1186/s13065-023-01043-9Development of Green HPTLC method for simultaneous determination of a promising combination Tamsulosin and Mirabegron: stability-indicating assay was examinedMaha M. Abou El-Alamin0Safaa S. Toubar1Dina A. Mohamed2Marwa I. Helmy3Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Helwan UniversityPharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Helwan UniversityPharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Helwan UniversityPharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Helwan UniversityAbstract Recently, mirabegron has been added to tamsulosin to treat overactive bladder in men with benign prostatic hypertrophy. A Rapid, selective, sensitive, and green high-performance thin-layer chromatography (HPTLC) approach was developed for the simultaneous determination of tamsulosin (TAM) and mirabegron (MIR) in pure and laboratory-prepared mixture. Complete separation was obtained on silica gel F254 using the solvent system methanol-ethyl acetate-ammonia (3:7:0.1, v/v). Short-wave ultraviolet light at 270 nm was used to view the chromatographic bands. For MIR and TAM, the suggested technique revealed compact spots with retention factor Rf values of 0.42 and 0.63, respectively. Within concentration ranges of 0.15–7.5 µg/band and 0.05–2.5 µg/band, good linearity was observed, with mean percentage recoveries of 100.04 ± 0.56 and 99.98% ± 0.95 for MIR and TAM, respectively. Green assessment of the developed HPTLC technique was estimated using different green analytical chemistry metrics such as Analytical eco-scale Analytical GREEness (AGREE), and Green Analytical Procedure Index (GAPI) metrics. The proposed method was effectively used as a stability-indicating assay to assess the presence of MIR and TAM in the pharmaceutical dosage form in the presence of their degradation product. The statistical analysis showed high precision and accuracy.https://doi.org/10.1186/s13065-023-01043-9Green assessmentHPTLCMirabegronTamsulosinStability study
spellingShingle Maha M. Abou El-Alamin
Safaa S. Toubar
Dina A. Mohamed
Marwa I. Helmy
Development of Green HPTLC method for simultaneous determination of a promising combination Tamsulosin and Mirabegron: stability-indicating assay was examined
BMC Chemistry
Green assessment
HPTLC
Mirabegron
Tamsulosin
Stability study
title Development of Green HPTLC method for simultaneous determination of a promising combination Tamsulosin and Mirabegron: stability-indicating assay was examined
title_full Development of Green HPTLC method for simultaneous determination of a promising combination Tamsulosin and Mirabegron: stability-indicating assay was examined
title_fullStr Development of Green HPTLC method for simultaneous determination of a promising combination Tamsulosin and Mirabegron: stability-indicating assay was examined
title_full_unstemmed Development of Green HPTLC method for simultaneous determination of a promising combination Tamsulosin and Mirabegron: stability-indicating assay was examined
title_short Development of Green HPTLC method for simultaneous determination of a promising combination Tamsulosin and Mirabegron: stability-indicating assay was examined
title_sort development of green hptlc method for simultaneous determination of a promising combination tamsulosin and mirabegron stability indicating assay was examined
topic Green assessment
HPTLC
Mirabegron
Tamsulosin
Stability study
url https://doi.org/10.1186/s13065-023-01043-9
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