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Stability study of simvastatin under hydrolytic conditions assessed by liquid chromatography

Authordc.contributor.authorÁlvarez Lueje, Alejandro 
Authordc.contributor.authorValenzuela, C. es_CL
Authordc.contributor.authorSquella Serrano, Juan es_CL
Authordc.contributor.authorNúñez Vergara, Luis es_CL
Cita de ítemdc.identifier.citationJOURNAL OF AOAC INTERNATIONAL 88(6):1631-1636en
Abstractdc.description.abstractIn this work, a liquid chromatography stability-indicating method was developed and applied to study the hydrolytic behavior of simvastatin in different pH values and temperatures. The selected chromatographic conditions were a C18 column; acetonitrile-28 mM phosphate buffer solution, pH 4 (65 + 35) as the mobile phase; 251 degrees C column temperature; and flow rate 1 mL/min. The developed method exhibited an adequate repeatability and reproducibility (coefficient of variation 0.54 and 0.74%, respectively) and a recovery higher than 98%. Furthermore, the detection and quantification limits were 9.1 x 10(-7) and 2.8 x 10(-6) M, respectively. The degradation of simvastatin fitted to pseudo-first order kinetics. The degradation was pH dependent, being much higher at alkaline pH than at acid pH. Activation energy, kinetic rate constants (k) at different temperatures, the half life (t(1/2)) and the time for 10% degradation to occur (t(90)) values are also reporteden
Publisherdc.publisherAOAC INTERNATIONALen
Keywordsdc.subjectLiquid chromatographyen
Títulodc.titleStability study of simvastatin under hydrolytic conditions assessed by liquid chromatographyen
Document typedc.typeArtículo de revistaen

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