STABILITY STUDY AND VALIDATED REVERSED PHASE LIQUID CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF TIROFIBAN HYDROCHLORIDE IN PRESENCE OF TYROSINE AS A PROCESS IMPURITY

ABSTRACT Tirofiban hydrochloride was subjected to the degradation under conditions of hydrolysis (acidic and alkaline degradation), oxidative, thermal and photolytic degradation as prescribed by ICH. A simple and precise liquid chromatographic method has been developed and validated for the simultan...

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Autores principales:	El-Bagary,Ramzia I., Elkady,Ehab F., Farid,Naira A., Youssef,Nadia F.
Lenguaje:	English
Publicado:	Sociedad Chilena de Química 2018
Materias:	Stability study Tirofiban hydrochloride monohydrate Tyrosine Reversed-phase liquid chromatography Method validation Intravenous infusion
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072018000203958
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spelling	oai:scielo:S0717-970720180002039582018-07-19STABILITY STUDY AND VALIDATED REVERSED PHASE LIQUID CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF TIROFIBAN HYDROCHLORIDE IN PRESENCE OF TYROSINE AS A PROCESS IMPURITYEl-Bagary,Ramzia I.Elkady,Ehab F.Farid,Naira A.Youssef,Nadia F. Stability study Tirofiban hydrochloride monohydrate Tyrosine Reversed-phase liquid chromatography Method validation Intravenous infusion ABSTRACT Tirofiban hydrochloride was subjected to the degradation under conditions of hydrolysis (acidic and alkaline degradation), oxidative, thermal and photolytic degradation as prescribed by ICH. A simple and precise liquid chromatographic method has been developed and validated for the simultaneous determination of tirofiban hydrochloride monohydrate (TIR) and its synthetic starting material; tyrosine (TRS). All the chromatographic separations were achieved on Zorbax SB C18, 250 mm×4.6 mm i.d., 5μm column at a flow rate of 1 mL min–1. Isocratic elution based on 0.1 M phosphate buffer (pH 3) - acetonitrile (70:30, v/v) with UV detection at 227 nm was applied. For the stability study separation of TIR from its degradation products was achieved using 0.1 M phosphate buffer (pH 3) - acetonitrile (72:28, v/v) with UV detection at 210 nm. Method validation parameters namely, linearity, accuracy and precision were found to be acceptable over the concentration ranges of 10-250 μg mL–1 for TIR and 1-70 μg mL–1 for TRS. The minimum detection limits were 1.76 μg mL–1 for TIR and 0.13 μg mL–1 for TRS. The optimized method was validated and proved to be specific, robust and accurate for the quality control of the cited drug in drug substance and drug product.info:eu-repo/semantics/openAccessSociedad Chilena de QuímicaJournal of the Chilean Chemical Society v.63 n.2 20182018-06-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072018000203958en10.4067/s0717-97072018000203958
institution	Scielo Chile
collection	Scielo Chile
language	English
topic	Stability study Tirofiban hydrochloride monohydrate Tyrosine Reversed-phase liquid chromatography Method validation Intravenous infusion
spellingShingle	Stability study Tirofiban hydrochloride monohydrate Tyrosine Reversed-phase liquid chromatography Method validation Intravenous infusion El-Bagary,Ramzia I. Elkady,Ehab F. Farid,Naira A. Youssef,Nadia F. STABILITY STUDY AND VALIDATED REVERSED PHASE LIQUID CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF TIROFIBAN HYDROCHLORIDE IN PRESENCE OF TYROSINE AS A PROCESS IMPURITY
description	ABSTRACT Tirofiban hydrochloride was subjected to the degradation under conditions of hydrolysis (acidic and alkaline degradation), oxidative, thermal and photolytic degradation as prescribed by ICH. A simple and precise liquid chromatographic method has been developed and validated for the simultaneous determination of tirofiban hydrochloride monohydrate (TIR) and its synthetic starting material; tyrosine (TRS). All the chromatographic separations were achieved on Zorbax SB C18, 250 mm×4.6 mm i.d., 5μm column at a flow rate of 1 mL min–1. Isocratic elution based on 0.1 M phosphate buffer (pH 3) - acetonitrile (70:30, v/v) with UV detection at 227 nm was applied. For the stability study separation of TIR from its degradation products was achieved using 0.1 M phosphate buffer (pH 3) - acetonitrile (72:28, v/v) with UV detection at 210 nm. Method validation parameters namely, linearity, accuracy and precision were found to be acceptable over the concentration ranges of 10-250 μg mL–1 for TIR and 1-70 μg mL–1 for TRS. The minimum detection limits were 1.76 μg mL–1 for TIR and 0.13 μg mL–1 for TRS. The optimized method was validated and proved to be specific, robust and accurate for the quality control of the cited drug in drug substance and drug product.
author	El-Bagary,Ramzia I. Elkady,Ehab F. Farid,Naira A. Youssef,Nadia F.
author_facet	El-Bagary,Ramzia I. Elkady,Ehab F. Farid,Naira A. Youssef,Nadia F.
author_sort	El-Bagary,Ramzia I.
title	STABILITY STUDY AND VALIDATED REVERSED PHASE LIQUID CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF TIROFIBAN HYDROCHLORIDE IN PRESENCE OF TYROSINE AS A PROCESS IMPURITY
title_short	STABILITY STUDY AND VALIDATED REVERSED PHASE LIQUID CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF TIROFIBAN HYDROCHLORIDE IN PRESENCE OF TYROSINE AS A PROCESS IMPURITY
title_full	STABILITY STUDY AND VALIDATED REVERSED PHASE LIQUID CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF TIROFIBAN HYDROCHLORIDE IN PRESENCE OF TYROSINE AS A PROCESS IMPURITY
title_fullStr	STABILITY STUDY AND VALIDATED REVERSED PHASE LIQUID CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF TIROFIBAN HYDROCHLORIDE IN PRESENCE OF TYROSINE AS A PROCESS IMPURITY
title_full_unstemmed	STABILITY STUDY AND VALIDATED REVERSED PHASE LIQUID CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF TIROFIBAN HYDROCHLORIDE IN PRESENCE OF TYROSINE AS A PROCESS IMPURITY
title_sort	stability study and validated reversed phase liquid chromatographic method for the determination of tirofiban hydrochloride in presence of tyrosine as a process impurity
publisher	Sociedad Chilena de Química
publishDate	2018
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072018000203958
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STABILITY STUDY AND VALIDATED REVERSED PHASE LIQUID CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF TIROFIBAN HYDROCHLORIDE IN PRESENCE OF TYROSINE AS A PROCESS IMPURITY

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