Application of HPLC to assess the compatibility of bisoprolol fumarate with selected excipients in mixtures by isothermal stress testing - 17/11/15
, P. Yerramothu b, M. Gorrepati c, S. Majeti b, S.K. Mamidala b, A. Nellutla bBenvenuto su EM|consulte, il riferimento dei professionisti della salute.
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Summary |
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 48h). 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%).
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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 48h). 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 %).
Il testo completo di questo articolo è disponibile in PDF.Keywords : Bisoprolol fumarate, Excipients, Mixtures, Compatibility, HPLC
Mots clés : Fumarate de bisoprolol, Excipients, Mélanges, Compatibilité, HPLC
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Vol 73 - N° 6
P. 442-451 - Novembre 2015 Ritorno al numero
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