Evaluation of the stability of hydrocortisone sodium succinate in solutions for parenteral use by a validated HPLC-UV method

Mihovec, Katja (author), Temova Rakuša, Žane (author), Gaál, Enikő Éva (author), Roškar, Robert (author)

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.

• Language: English
• Keywords: forced degradation study, in-use stability, infusion, injection, Solu-Cortef
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: FFA - Faculty of Pharmacy
• Publication status: Published
• Publication version: Version of Record
• Year: 2022
• Number of pages: Str. 796–802
• Numbering: Vol. 69, no. 4
• PID: 20.500.12556/RUL-143887
• UDC: 541.8+532.7
• ISSN on article: 1580-3155
• DOI: 10.17344/acsi.2022.7539
• COBISS.SI-ID: 125575171
• Publication date in RUL: 18.01.2023

Record is a part of a journal

• Title: Acta chimica slovenica
• Shortened title: Acta chim. slov.
• Publisher: Slovensko kemijsko društvo, =Slovenian Chemical Society
• ISSN: 1580-3155
• COBISS.SI-ID: 21870085

Secondary language

• Language: Slovenian

Abstract

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.

• Keywords: študija prisilne razgradnje, stabilnost med uporabo, infuzija, injekcija, rok uporabnosti po odprtju, Solu-Cortef

Projects

• Funder: ARRS - Slovenian Research Agency
• Project number: P1-0189-2018
• Name: Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih