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

• Published in: Journal of the Chilean Chemical Society Vol. 63; no. 2; pp. 3958 - 3967
• Main Authors: El-Bagary, Ramzia I., Elkady, Ehab F., Farid, Naira A., Youssef, Nadia F.
• Format: Journal Article
• Language: English; Portuguese
• Published: Sociedad Chilena de Química 01.06.2018
• Subjects: CHEMISTRY, MULTIDISCIPLINARY; Tyrosine; Reversed-phase liquid chromatography; Tirofiban hydrochloride monohydrate; Intravenous infusion; Method validation; Stability study
• ISSN: 0717-9707; 0717-9707
• DOI: 10.4067/s0717-97072018000203958

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.