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Stability and compatibility of methotrexate and dexamethasone in 0.9% sodium chloride for intrathecal injection

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dc.contributor.author Xu, Fan
dc.contributor.author Zeng, Su
dc.date.accessioned 2022-10-18T10:28:07Z
dc.date.available 2022-10-18T10:28:07Z
dc.date.issued 2020-11-01
dc.identifier.citation Xu, F., & Zeng, S. (2020). Stability and compatibility of methotrexate and dexamethasone in 0.9% sodium chloride for intrathecal injection. Pakistan Journal of Pharmaceutical Sciences, 33(6), 2477-2482. en_US
dc.identifier.issn 1011-601X
dc.identifier.uri http://142.54.178.187:9060/xmlui/handle/123456789/13202
dc.description.abstract The stability of a mixture of methotrexate and dexamethasone sodium phosphate in 0.9% sodium chloride for intrathecal (IT) injection was assessed. To simulate the clinically used concentrations of the admixtures, 2mL of 0.9% sodium chloride was added into each of two vials of methotrexate. Both solution mixtures were then transferred into an intrathecal injector. A vial of dexamethasone sodium phosphate (5mg in 1mL) was subsequently added directly to the injector to obtain a mixture of 2mg/mL methotrexate and 1mg/mL dexamethasone. Subsequently, stability as assessed by visual evaluation of color changes, regular pH monitoring, monitoring of changes in particulate contents and drug concentrations in the admixture, and detection of impurities with HPLC- UV-TOF/MS before and after mixing. The results showed that admixtures were clear, no color changes were observed and the pH value remained stable under normal fluorescent room light. The ≥25-μm and ≥10-μm particulate content levels were low and within specification limits. The concentrations of methotrexate and dexamethasone exhibited no significant changes. Impurity peaks before and after mixing were not increased and no new degradation products were detected after mixing. Methotrexate and dexamethasone sodium phosphate did not affect each other’s stability. en_US
dc.language.iso en en_US
dc.publisher Karachi:Pakistan Journal of Pharmaceutical Sciences, university of Karachi. en_US
dc.subject Methotrexate en_US
dc.subject dexamethasone sodium phosphate en_US
dc.subject 0.9% sodium chloride injection en_US
dc.subject compatibility, stability en_US
dc.title Stability and compatibility of methotrexate and dexamethasone in 0.9% sodium chloride for intrathecal injection en_US
dc.type Article en_US


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