Stability indicating MLC method for three novel deriviatives of zidovudine in aqueous and simulated gastric and intestinal fluids.
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Otros documentos de la autoría: Esteve-Romero, Josep; Raviolo, Mónica A.; Briñón, Margarita C.
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http://dx.doi.org/10.1016/j.chroma.2011.02.018 |
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Título
Stability indicating MLC method for three novel deriviatives of zidovudine in aqueous and simulated gastric and intestinal fluids.Fecha de publicación
2011-05Editor
© 2011 ElsevierISSN
0021-9673Tipo de documento
info:eu-repo/semantics/articleVersión de la editorial
http://www.sciencedirect.com/science/article/pii/S0021967311002135Versión
info:eu-repo/semantics/publishedVersionPalabras clave / Materias
Resumen
This work studies the stability of three new anti-HIV agents which were obtained by the association of zidovudine (AZT) with different amino acids, such as leucine (AZT-Leu) and valine (AZT-Val), and one with an acid ... [+]
This work studies the stability of three new anti-HIV agents which were obtained by the association of zidovudine (AZT) with different amino acids, such as leucine (AZT-Leu) and valine (AZT-Val), and one with an acid group (AZT-Ac). Before commercialisation, their stability in different matrices – simulated gastric fluid (SGF, pH 1.2) and simulated intestinal fluid (SIF, pH 6.8), both as the USP 32 Guideline indicates, and buffers (pH 1.2 and 6.8) – must be studied. To this end, a new stability-indicating micellar liquid chromatography (MLC) method has been optimised and validated. Measurements were based on the disappearance of reagents and the appearance of the only degradation product (AZT). This optimised and validated method used a C18 column and a mobile phase containing 0.05 M sodium dodecyl sulphate–1% (v/v)1-butanol–0.01 M NaH2PO4 (pH 3.0) at 30 °C, and a flow rate of 1 mL min−1. Under these conditions, retention times were 1.4, 3.6, 6.3 and 9.5 min for AZT-Ac, AZT, AZT-Val and AZT-Leu, respectively. Calibrations better than 0.9995, intra- and inter-day precisions below 1.08% and good recoveries (94.47–116.52%) and robustness (RSD less that 1.08%) were obtained and were adequate to analyse the four compounds. Finally, this MLC method was applied to achieve stability studies which resulted in the evidence that all the compounds followed a pseudo-first-order kinetics, and in the determination of their kinetic constants and half-life time. A reference method, applied in the same studies, validated the MLC method reported herein. [-]
Publicado en
Journal of Chromatography A (May 2011), vol. 1218, no. 18, 2540–2545Derechos de acceso
http://rightsstatements.org/vocab/CNE/1.0/
info:eu-repo/semantics/restrictedAccess
info:eu-repo/semantics/restrictedAccess
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