| dc.creator | El-Bagary, Ramzia I. | |
| dc.creator | Elkady, Ehab F. | |
| dc.creator | Farid, Naira A. | |
| dc.creator | Youssef, Nadia F. | |
| dc.date | 2018-06-25 | |
| dc.date.accessioned | 2019-11-13T15:11:47Z | |
| dc.date.available | 2019-11-13T15:11:47Z | |
| dc.identifier | http://www.jcchems.com/index.php/JCCHEMS/article/view/679 | |
| dc.identifier.uri | https://revistaschilenas.uchile.cl/handle/2250/112683 | |
| dc.description | 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. | en-US |
| dc.format | application/pdf | |
| dc.language | eng | |
| dc.publisher | Sociedad Chilena de Química | en-US |
| dc.relation | http://www.jcchems.com/index.php/JCCHEMS/article/view/679/237 | |
| dc.rights | Copyright (c) 2018 Journal of the Chilean Chemical Society | en-US |
| dc.rights | https://creativecommons.org/licenses/by-nc-sa/4.0 | en-US |
| dc.source | Journal of the Chilean Chemical Society; Vol 63 No 2 (2018): Journal of the Chilean Chemical Society | en-US |
| dc.source | 0717-9707 | |
| dc.source | 0717-9324 | |
| dc.subject | Stability study | en-US |
| dc.subject | Tirofiban hydrochloride monohydrate | en-US |
| dc.subject | Tyrosine | en-US |
| dc.subject | Reversed-phase liquid chromatography | en-US |
| dc.subject | Method validation | en-US |
| dc.subject | Intravenous infusion | en-US |
| dc.title | STABILITY STUDY AND VALIDATED REVERSED PHASE LIQUID CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF TIROFIBAN HYDROCHLORIDE IN PRESENCE OF TYROSINE AS A PROCESS IMPURITY | en-US |
| dc.type | info:eu-repo/semantics/article | |
| dc.type | info:eu-repo/semantics/publishedVersion | |
