RESUMO
OBJECTIVE: To study the compatibility of tirofiban HCl injection 0-05 mg/ml with dopamine HCl, famotidine, sodium heparin, lidocaine HCl and potassium chloride infusion solutions during simulated Y-site administration. METHOD: Tirofiban HCl, dopamine HCl, famotidine, lidocaine HCl and potassium chloride infusions were each prepared from their respective concentrates as per current clinical preparation instructions in both 0.9% sodium chloride and 5% dextrose solutions at both the minimum and maximum concentrations normally administered. Sodium heparin premixed infusion solutions in 5% dextrose and 0-45% sodium chloride were used as-is. Tirofiban HCl solutions were combined 1:1 (simulated Y-site administration) with the dopamine HCl, famotidine, sodium heparin, lidocaine HCl and potassium chloride solutions in separate glass containers and polyvinylchloride Y-site infusion lines. Samples were held for 4 h at room temperature under ambient fluorescent light and were assayed for changes in drug content, degradation, pH, appearance and turbidity. Activity of sodium heparin solutions was measured using an aPTT coagulation assay. RESULTS: All mixtures remained clear and colourless with no visual indication of instability, i.e. precipitation. Clarity of solutions was confirmed by turbidometric analysis. There was no significant loss of drug, increase in known degradates, or appearance of unknown drug-related peaks as determined by HPLC. The activity of heparin in heparin-containing solutions remained unchanged. The pH of all test-solutions remained constant. CONCLUSION: Tirofiban HCl injection 0.05 mg/ml can be co-infused by Y-site administration with dopamine HCl, famotidine, sodium heparin, lidocaine HCl and potassium chloride injection solutions.
Assuntos
Inibidores da Agregação Plaquetária/química , Tirosina/análogos & derivados , Cromatografia Líquida de Alta Pressão , Dopamina/administração & dosagem , Dopamina/química , Incompatibilidade de Medicamentos , Estabilidade de Medicamentos , Famotidina/administração & dosagem , Famotidina/química , Heparina/administração & dosagem , Heparina/farmacologia , Concentração de Íons de Hidrogênio , Injeções Intravenosas , Lidocaína/administração & dosagem , Lidocaína/química , Inibidores da Agregação Plaquetária/administração & dosagem , Cloreto de Potássio/administração & dosagem , Cloreto de Potássio/química , Fatores de Tempo , Tirofibana , Tirosina/administração & dosagem , Tirosina/químicaRESUMO
A sensitive and specific method based in solid-phase extraction and reverse-phase liquid chromatography was developed and validated for the quantitation of L-768673 in a microemulsion formulation. Following a water wash, the drug was eluted from the extraction column with acetonitrile and was analyzed on a reverse-phase C18 column with UV detection at 245 nm. The mobile phase consisted of acetonitrile-0.2% trifluoroacetic acid, 0.1% triethylamine (53:47 v/v). The retention time L-768673 was approximately 28 min with a flow rate of 1.5 ml min-1.