ASSESSMENT OF THE HYDROLYTIC DEGRADATION OF LOVASTATIN BY HPLC

In this work an HPLC stability-indicating method was developed and applied to study the hydrolytic behaviour of lovastatin in different simulated fluids. The selected chromatographic conditions were a C-18 column, acetonitrile/methanol/phosphate buffer solution pH 4 (32/33/35) as mobile phase, 45ºC...

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Autores principales:	ÁLVAREZ-LUEJE,A, PASTINE,J, SQUELLA,J.A, NUÑEZ-VERGARA,L.J
Lenguaje:	English
Publicado:	Sociedad Chilena de Química 2005
Materias:	lovastatin HPLC hydrolysis stability simulated fluids
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072005000400002
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spelling	oai:scielo:S0717-970720050004000022006-04-19ASSESSMENT OF THE HYDROLYTIC DEGRADATION OF LOVASTATIN BY HPLCÁLVAREZ-LUEJE,APASTINE,JSQUELLA,J.ANUÑEZ-VERGARA,L.J lovastatin HPLC hydrolysis stability simulated fluids In this work an HPLC stability-indicating method was developed and applied to study the hydrolytic behaviour of lovastatin in different simulated fluids. The selected chromatographic conditions were a C-18 column, acetonitrile/methanol/phosphate buffer solution pH 4 (32/33/35) as mobile phase, 45ºC temperature column, flux of 1.5 mL/min and UV detection at 238 nm. The developed method exhibited an adequate repeatability and reproducibility (CV 0.057% and 0.73%, respectively) and a recovery higher than 98%. Furthermore, the detection and quantitation limits were 9.1×10-7 M and 2.8×10-6 M. Lovastastin exhibited a pH-dependent degradation with an instantaneous hydrolysis in alkaline media at room temperature. One or two degradation products could be observed when lovastatin is hydrolyzed in alkaline or acid medium, respectively. The degradation products from lovastatin retain the UV-spectra of the parent drug, evidencing that the chromophore structure remains unaltered. Also, lovastatin hydrolysis in different media follows a pseudo first-order kinetic. The rank-order for lovastatin stability in different media was: simulated gastric medium without pepsin > 0.06 M HCl > 0.1 M HCl > phosphate buffer pH 7.4 + sodium laurylsulphate > phosphate buffer pH 7.4info:eu-repo/semantics/openAccessSociedad Chilena de QuímicaJournal of the Chilean Chemical Society v.50 n.4 20052005-12-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072005000400002en10.4067/S0717-97072005000400002
institution	Scielo Chile
collection	Scielo Chile
language	English
topic	lovastatin HPLC hydrolysis stability simulated fluids
spellingShingle	lovastatin HPLC hydrolysis stability simulated fluids ÁLVAREZ-LUEJE,A PASTINE,J SQUELLA,J.A NUÑEZ-VERGARA,L.J ASSESSMENT OF THE HYDROLYTIC DEGRADATION OF LOVASTATIN BY HPLC
description	In this work an HPLC stability-indicating method was developed and applied to study the hydrolytic behaviour of lovastatin in different simulated fluids. The selected chromatographic conditions were a C-18 column, acetonitrile/methanol/phosphate buffer solution pH 4 (32/33/35) as mobile phase, 45ºC temperature column, flux of 1.5 mL/min and UV detection at 238 nm. The developed method exhibited an adequate repeatability and reproducibility (CV 0.057% and 0.73%, respectively) and a recovery higher than 98%. Furthermore, the detection and quantitation limits were 9.1×10-7 M and 2.8×10-6 M. Lovastastin exhibited a pH-dependent degradation with an instantaneous hydrolysis in alkaline media at room temperature. One or two degradation products could be observed when lovastatin is hydrolyzed in alkaline or acid medium, respectively. The degradation products from lovastatin retain the UV-spectra of the parent drug, evidencing that the chromophore structure remains unaltered. Also, lovastatin hydrolysis in different media follows a pseudo first-order kinetic. The rank-order for lovastatin stability in different media was: simulated gastric medium without pepsin > 0.06 M HCl > 0.1 M HCl > phosphate buffer pH 7.4 + sodium laurylsulphate > phosphate buffer pH 7.4
author	ÁLVAREZ-LUEJE,A PASTINE,J SQUELLA,J.A NUÑEZ-VERGARA,L.J
author_facet	ÁLVAREZ-LUEJE,A PASTINE,J SQUELLA,J.A NUÑEZ-VERGARA,L.J
author_sort	ÁLVAREZ-LUEJE,A
title	ASSESSMENT OF THE HYDROLYTIC DEGRADATION OF LOVASTATIN BY HPLC
title_short	ASSESSMENT OF THE HYDROLYTIC DEGRADATION OF LOVASTATIN BY HPLC
title_full	ASSESSMENT OF THE HYDROLYTIC DEGRADATION OF LOVASTATIN BY HPLC
title_fullStr	ASSESSMENT OF THE HYDROLYTIC DEGRADATION OF LOVASTATIN BY HPLC
title_full_unstemmed	ASSESSMENT OF THE HYDROLYTIC DEGRADATION OF LOVASTATIN BY HPLC
title_sort	assessment of the hydrolytic degradation of lovastatin by hplc
publisher	Sociedad Chilena de Química
publishDate	2005
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072005000400002
work_keys_str_mv	AT alvarezluejea assessmentofthehydrolyticdegradationoflovastatinbyhplc AT pastinej assessmentofthehydrolyticdegradationoflovastatinbyhplc AT squellaja assessmentofthehydrolyticdegradationoflovastatinbyhplc AT nunezvergaralj assessmentofthehydrolyticdegradationoflovastatinbyhplc
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ASSESSMENT OF THE HYDROLYTIC DEGRADATION OF LOVASTATIN BY HPLC

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