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  • Sociedad Chilena de Química
  • Journal of the Chilean Chemical Society
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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

Author
El-Bagary, Ramzia I.

Elkady, Ehab F.

Farid, Naira A.

Youssef, Nadia F.

Full text
https://www.jcchems.com/index.php/JCCHEMS/article/view/679
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.
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Artes, Arquitectura y UrbanismoCiencias Agrarias, Forestales y VeterinariasCiencias Exactas y NaturalesCiencias SocialesDerechoEconomía y AdministraciónFilosofía y HumanidadesIngenieríaMedicinaMultidisciplinarias
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Universidad de ChileUniversidad Católica de ChileUniversidad de Santiago de ChileUniversidad de ConcepciónUniversidad Austral de ChileUniversidad Católica de ValparaísoUniversidad del Bio BioUniversidad de ValparaísoUniversidad Católica del Nortemore

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