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

• Published in: BMC chemistry 2023-09, Vol.17 (1), p.130-130, Article 130
• Main Authors: Abou El-Alamin, Maha M., Toubar, Safaa S., Mohamed, Dina A., Helmy, Marwa I.
• Format: Article
• Language: English
• Subjects: Acetates; Ammonia; Analytical chemistry; Chemistry; Chemistry and Materials Science; Chemistry/Food Science; Chromatography; Esters; Ethyl acetate; Green assessment; HPTLC; Ions; Mathematical analysis; Methanol; Methods; Mirabegron; Silica gel; Stability analysis; Stability study; Statistical analysis; Sustainable development; Tamsulosin; Tamsulosin hydrochloride; Thin layer chromatography; Ultraviolet radiation; Urinary incontinence
• ISSN: 2661-801X; 2661-801X
• DOI: 10.1186/s13065-023-01043-9

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 F 254 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 R f 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.