| Autor: |
David, Palmero, Emilienne, Chavan, Markoulina, Berger-Gryllaki, Jean-François, Tolsa, Ermindo R, Di Paolo, André, Pannatier, Hugues, Henry, Farshid, Sadeghipour |
| Rok vydání: |
2017 |
| Předmět: |
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| Zdroj: |
European journal of hospital pharmacy : science and practice. 25(e2) |
| ISSN: |
2047-9964 |
| Popis: |
OBJECTIVE: We aimed to monitor the physicochemical stability of prostaglandin E(1) (PGE(1)) 1.5 and 15 µg/mL in 10% dextrose stored in polypropylene syringes. METHODS: We developed a liquid chromatography-high resolution mass spectrometry (LC-HRMS) method to detect and quantify levels of PGE(1). Method selectivity was performed with a mixture of PGE(1) and its degradation products. Forced degradation tests were performed to determine which degradation products were most likely to form. PGE(1) injection solutions in 10% dextrose were stored in unprotected and shielded-from-light polypropylene syringes in a climatic chamber. Samples were taken immediately after preparation (T(0)) and after 24, 48, 72 and 168 hours for analysis. PGE(1) solutions were considered stable if ≥90.0% of the initial concentration was retained. RESULTS: The LC-HRMS method was validated in the range of 0.086-0.200µg/mL PGE(1) with trueness values between 98.2% and 100.3%, and repeatability and intermediate precision values of |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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