Palmero David, Chavan Emilienne, Berger-Gryllaki Markoulina, Tolsa Jean-François, Di Paolo Ermindo R, Pannatier André, Henry Hugues, Sadeghipour Farshid
Department of Pharmacy, Lausanne University Hospital, Lausanne, Switzerland.
School of Pharmaceutical Sciences, Geneva and Lausanne Universities, Geneva, Switzerland.
Eur J Hosp Pharm. 2018 Oct;25(e2):e109-e114. doi: 10.1136/ejhpharm-2017-001205. Epub 2017 Aug 2.
We aimed to monitor the physicochemical stability of prostaglandin E (PGE) 1.5 and 15 µg/mL in 10% dextrose stored in polypropylene syringes.
We developed a liquid chromatography-high resolution mass spectrometry (LC-HRMS) method to detect and quantify levels of PGE. Method selectivity was performed with a mixture of PGE and its degradation products. Forced degradation tests were performed to determine which degradation products were most likely to form. PGE 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) and after 24, 48, 72 and 168 hours for analysis. PGE solutions were considered stable if ≥90.0% of the initial concentration was retained.
The LC-HRMS method was validated in the range of 0.086-0.200µg/mL PGE 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. PGE and its degradation products were resolved chromatographically. PGE 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 A was the sole degradation product observed.
A LC-HRMS method to evaluate PGE stability in a 10% dextrose was developed and validated. PGE 1.5 and 15µg/mL in 10% dextrose solution are stable for 48hours when stored at 30ºC in UPL polypropylene syringes.
我们旨在监测前列腺素E（PGE）在10%葡萄糖溶液中1.5和15µg/mL浓度下，储存在聚丙烯注射器中的物理化学稳定性。
我们开发了一种液相色谱-高分辨率质谱（LC-HRMS）方法来检测和定量PGE的水平。用PGE及其降解产物的混合物进行方法选择性测试。进行强制降解试验以确定最有可能形成的降解产物。10%葡萄糖溶液中的PGE注射溶液分别储存在气候箱中未加保护和避光的聚丙烯注射器中。制备后立即（T）以及24、48、72和168小时后取样进行分析。如果保留初始浓度的≥90.0%，则认为PGE溶液稳定。
LC-HRMS方法在0.086 - 0.200µg/mL PGE范围内得到验证，真实值在98.2%至100.3%之间，重复性和中间精密度值分别<2.2%和<4.7%。该方法的定量限和检测限分别为0.086和0.026µg/mL。PGE及其降解产物通过色谱法分离。在未避光（UPL）注射器中，PGE注射溶液在48小时后稳定性≥90.0%。溶液保持澄清，无沉淀、颜色或pH值变化，且亚可见颗粒在允许水平内。观察到的唯一降解产物是前列腺素A。
开发并验证了一种用于评估10%葡萄糖溶液中PGE稳定性的LC-HRMS方法。10%葡萄糖溶液中1.5和15µg/mL的PGE在30ºC下储存在UPL聚丙烯注射器中时，48小时内稳定。
