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Annales pharmaceutiques francaises

Annales pharmaceutiques francaises

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Application of HPLC to assess the compatibility of bisoprolol fumarate with selected excipients in mixtures by isothermal stress testing

Published:1 November 2015 DOI: 10.1016/j.pharma.2015.05.001 PMID: 26142745
V.K. Marothu , P. Yerramothu , M. Gorrepati , S. Majeti , S.K. Mamidala , A. Nellutla

Abstract

In the present study, the compatibility between bisoprolol fumarate and selected excipients (ascorbic acid, citric acid anhydrous, butylated hydroxyanisole, polyvinylpyrrolidone, glycerol, mannitol and sorbitol) in mixtures (1:10 ratio of drug and excipient) was investigated by subjecting the samples to isothermal stress conditions (90?°C for 48?h). A new HPLC method was developed, validated and employed for determining the drug content of the stressed compatibility samples. Results of HPLC revealed that major degradation of bisoprolol fumarate was observed with butylated hydroxyanisole (89.4%), citric acid anhydrous (89%), mannitol (77%) and glycerol (61.9%).

La compatibilité entre le fumarate de bisoprolol et des excipients (acides ascorbique et citrique?; butyle hydroxyanisole, polyvinylpyrrolidone, glycérol, mannitol et sorbitol en mélange (1:10?principe actif/excipient) a été étudiée en exposant les échantillons dans des conditions de stress isothermique (90?°C durant 48?h). Une nouvelle méthode HPLC a été développée, validée et utilisée pour déterminer la quantité de principe actif restante dans les échantillons stressés. Les résultats ont montré une dégradation majeure du fumarate de bisoprolol avec le butyle hydroxyanisole (89,4?%), l’acide citrique anhydre (89?%), le mannitol (77?%) et le glycérol (61,9?%).

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Related products
Procduct Name CAS Molecular Formula Supplier Price
Citric acid 77-92-9 C6H8O7 1801 suppliers $5.00-$2290.00
Glycerol 56-81-5 C3H8O3 1786 suppliers $5.00-$6250.00
Ascorbic Acid 50-81-7 C6H8O6 1630 suppliers $6.00-$2170.00
Sorbitol 50-70-4 C6H14O6 833 suppliers $5.00-$2150.00
Polyvinylpyrrolidone 9003-39-8 CH4 813 suppliers $15.00-$9201.92
Butylated hydroxyanisole 25013-16-5 C11H16O2 594 suppliers $5.00-$377.00
Bisoprolol fumarate 104344-23-2 C22H35NO8 581 suppliers $28.00-$925.00
Mannitol 87-78-5 C6H14O6 434 suppliers Inquiry
BISOPROLOL FUMARATE 105878-43-1 C22H35NO8 4 suppliers $25.00-$113.00
BISOPROLOL FUMARATE 66722-45-0 C22H35NO5 4 suppliers Inquiry

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