RT Journal Article SR Electronic T1 Stability of prostaglandin E1 solutions stored in polypropylene syringes for continuous intravenous administration to newborns JF European Journal of Hospital Pharmacy JO Eur J Hosp Pharm FD British Medical Journal Publishing Group SP e109 OP e114 DO 10.1136/ejhpharm-2017-001205 VO 25 IS e2 A1 David Palmero A1 Emilienne Chavan A1 Markoulina Berger-Gryllaki A1 Jean-François Tolsa A1 Ermindo R Di Paolo A1 André Pannatier A1 Hugues Henry A1 Farshid Sadeghipour YR 2018 UL http://ejhp.bmj.com/content/25/e2/e109.abstract AB Objective We aimed to monitor the physicochemical stability of prostaglandin E1 (PGE1) 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 PGE1. Method selectivity was performed with a mixture of PGE1 and its degradation products. Forced degradation tests were performed to determine which degradation products were most likely to form. PGE1 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 (T0) and after 24, 48, 72 and 168 hours for analysis. PGE1 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 PGE1 with trueness values between 98.2% and 100.3%, and repeatability and intermediate precision values of <2.2%and <4.7%, respectively. The quantification and detection limits of the method were 0.086 and 0.026µg/mL, respectively. PGE1 and its degradation products were resolved chromatographically. PGE1 injection solutions were≥90.0%stable after 48hours in unprotected from light (UPL) syringes. The solutions remained clear without precipitation, colour or pH modification and subvisible particles within the permitted levels. Prostaglandin A1 was the sole degradation product observed.Conclusions A LC-HRMS method to evaluate PGE1 stability in a 10% dextrose was developed and validated. PGE1 1.5 and 15µg/mL in 10% dextrose solution are stable for 48hours when stored at 30ºC in UPL polypropylene syringes.