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dc.contributor.author
Gualdesi, María Soledad
dc.contributor.author
Esteve Romero, Josep
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Briñon, Margarita Cristina
dc.contributor.author
Raviolo, Mónica Ana
dc.date.available
2017-08-31T20:13:07Z
dc.date.issued
2013-02
dc.identifier.citation
Gualdesi, María Soledad; Esteve Romero, Josep; Briñon, Margarita Cristina; Raviolo, Mónica Ana; Development and validation of a stability indicating method for seven novel derivatives of lamivudine with anti-HIV and anti-HBV activity in simulated gastric and intestinal fluids; Elsevier Science; Journal of Pharmaceutical and Biomedical Analysis; 78-79; 2-2013; 52-56
dc.identifier.issn
0731-7085
dc.identifier.uri
http://hdl.handle.net/11336/23389
dc.description.abstract
A simple micellar liquid chromatography (MLC) method has been developed and validated for use in stability indicating studies of lamivudine and its carbonate derivatives with proved activity against human immunodeficiency and hepatitis B viruses (HIV and HBV, respectively), in simulated gastric (SGF) and intestinal (SIF) fluids samples. The optimized method involves a C18 column thermostated at 30 °C, UV detection at 272 nm, a flow rate of 1.0 mL min−1 and a micellar mobile phase composed by 0.15 M sodium dodecyl sulphate (SDS) – 4% (v/v) 1-butanol – 0.01 M KH2PO4–Na2HPO4 (pH 7), using zidovudine (AZT) as internal standard. Validation under Food and Drug Administration (FDA) guideline of the analytical parameters include: linearity (r2 > 0.9996), LODs (1.6 × 10−7–6.9 × 10−6 M) and LOQ (1 × 10−5 M), intra (0.02–1.48%) and inter-day precision (0.04–1.66%) expressed as relative standard deviation (R.S.D.), and robustness parameters (less than 1.98%). Using this method, recoveries ranging from 92.9 to 119% were obtained for the eight substances. Thus, this method provides a simple, sensitive, accurate and precise assay for the determination of all compounds that can be readily adaptable to routine use by clinical laboratories with standard equipment. In addition, we evaluated the stability of carbonates of lamivudine in buffer pH 1.2 and 6.8; SGF (pH 1.2) and SIF one (pH 6.8), all as indicated in United States Pharmacopeia (USP) 32. Finally, this chromatographic method was applied to stability studies which resulted in all the compounds following a pseudo-first-order kinetics, and in the determination of its kinetic constant and half-life time.
dc.format
application/pdf
dc.language.iso
eng
dc.publisher
Elsevier Science
dc.rights
info:eu-repo/semantics/openAccess
dc.rights.uri
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
dc.subject
Lamivudine Derivatives
dc.subject
Micellar Liquid Chromatography
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Simulated Gastric And Intestinal Fluids
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Pharmacokinetics
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Otras Ciencias Químicas
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Ciencias Químicas
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CIENCIAS NATURALES Y EXACTAS
dc.title
Development and validation of a stability indicating method for seven novel derivatives of lamivudine with anti-HIV and anti-HBV activity in simulated gastric and intestinal fluids
dc.type
info:eu-repo/semantics/article
dc.type
info:ar-repo/semantics/artículo
dc.type
info:eu-repo/semantics/publishedVersion
dc.date.updated
2017-08-30T13:53:32Z
dc.journal.volume
78-79
dc.journal.pagination
52-56
dc.journal.pais
Países Bajos
dc.journal.ciudad
Amsterdam
dc.description.fil
Fil: Gualdesi, María Soledad. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Departamento de Farmacia; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
dc.description.fil
Fil: Esteve Romero, Josep. Universitat Jaume I; España
dc.description.fil
Fil: Briñon, Margarita Cristina. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Departamento de Farmacia; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
dc.description.fil
Fil: Raviolo, Mónica Ana. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Departamento de Farmacia; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
dc.journal.title
Journal of Pharmaceutical and Biomedical Analysis
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.1016/j.jpba.2013.01.027
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/http://www.sciencedirect.com/science/article/pii/S0731708513000368
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