20.500.12556/RUL-143887 Evaluation of the stability of hydrocortisone sodium succinate in solutions for parenteral use by a validated HPLC-UV method This study aimed to determine the in-use stability (t95%) of hydrocortisone sodium succinate (HSS) infusion solutions and provide evidence-based guidelines on their usability. HSS infusion solutions were prepared and stored as recommended by the manufacturer and under common conditions in our hospital. The effects of HSS concentration (1 and 4 mg/mL), solvent (isotonic saline and glucose), temperature (ambient and 30°C), and light on its stability were evaluated using a validated stability-indicating HPLC-UV method. HSS degradation followed first-order kinetics. No significant difference in its stability was observed between the two evaluated concentrations, solvents and light exposure (t95% between 25 and 30 h). Elevated temperature (30°C) affected HSS stability and significantly reduced the t95% (4.6-6.3 h). HSS infusion solutions are physically and chemically stable (˂5% degradation) for at least 6 h if stored below 30°C. The in-use stability may be extended up to 24 h if stored below 24°C. Namen te študije je opredelitev stabilnosti in določitev roka uporabnosti med uporabo (t95%) raztopin za infundiranje z natrijevim hidrokortizonsukcinatom (HSS) ter zagotovitev na dokazih podprtih priporočil o njihovi uporabnosti. Infuzijske raztopine HSS smo pripravili in shranjevali v skladu s priporočili proizvajalca in pri običajnih pogojih v naši bolnišnici. Z validirano stabilnostno indikativno HPLC-UV metodo smo ugotavljali vpliv koncentracije HSS (1 in 4 mg/mL), topila (izotonična fiziološka raztopina in raztopina glukoze), temperature (sobna in 30 °C) in svetlobe na njegovo stabilnost. Razgradnja HSS je sledila kinetiki prvega reda. Ugotovili smo, da različni preiskovani koncentraciji HSS, obe topili in izpostavljenost svetlobi niso značilno vplivali na stabilnost HSS (t95% med 25 in 30 urami), medtem ko je povišana temperatura (30 °C) značilno skrajšala t95% (4,6–6,3 ur). Infuzijske raztopine HSS so fizikalno in kemično stabilne (<5 % razgradnja) vsaj 6 ur pri temperaturi do 30 °C in najdlje 24 ur pri temperaturi do 24 °C. forced degradation study in-use stability infusion injection Solu-Cortef študija prisilne razgradnje stabilnost med uporabo infuzija injekcija rok uporabnosti po odprtju Solu-Cortef true false true Angleški jezik Slovenski jezik Članek v reviji 2023-01-18 07:59:47 2023-01-18 07:59:51 2023-01-27 03:35:11 0000-00-00 00:00:00 2022 0 0 Str. 796–802 no. 4 Vol. 69 2022 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 541.8+532.7 1580-3155 10.17344/acsi.2022.7539 125575171 7539-54946-1-PB.pdf 7539-54946-1-PB.pdf 1 ABFAD8A519D033D5BD53976AD163FAD4 0c91133033d34b95ddb91dc85dbe0c6b504698c427310b97d94a9ed3f6bb2347 a8f87379-96fd-11ed-9c94-00155dcfd717 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=165939 https://journals.matheo.si/index.php/ACSi/article/view/7539 1 7666d562-96fd-11ed-9c94-00155dcfd717 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=165937 Fakulteta za farmacijo 0 0 0