Extended stability study of an extemporaneously analgesic solution of clonidine, ropivacaine and fentanyl

The aim of this work was to perform an extended stability study for the analgesic containing fentanyl, clonidine and ropivacaine in physiological saline solution 0.9% at different infusion sites, such as infusion bags, epidural infusion sets and syringes. The extended stability was assessed by an HP...

ver descrição completa

Detalhes bibliográficos
Autores: Oliveira, Alessandra Moreira, Gonçalves, Jose Carlos Saraiva, Estrela, Rita de Cássia Elias
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:Brasil
Recursos:Universidade de São Paulo (USP)
Repositorio:Brazilian Journal of Pharmaceutical Sciences
Idioma:inglés
OAI Identifier:oai:revistas.usp.br:article/207711
Acesso em linha:https://www.revistas.usp.br/bjps/article/view/207711
Access Level:acceso abierto
Palavra-chave:Cancer
Clonidine
Extended stability
Fentanyl
Ropivacaine
Descrição
Resumo:The aim of this work was to perform an extended stability study for the analgesic containing fentanyl, clonidine and ropivacaine in physiological saline solution 0.9% at different infusion sites, such as infusion bags, epidural infusion sets and syringes. The extended stability was assessed by an HPLC system equipped with a photodiode array detector set at 210 nm. The separation was conducted on a C18 column maintained at 40˚C and using an isocratic mobile phase consisted of buffer solution-methanol-acetonitrile (45:45:10, v/v/v). The presence of particulate matter and the pH of each solution were also investigated. Twenty-four hours after the preparation, the formation of one suspected product was observed and for all drugs, in 24 hours it was observed the concentration decrease in different sets (PVC infusion bags, syringes and epidural infusion administration sets). The pH values of each solution varied no more than 5% during the study and no particle was observed. Conclusion: The extended stability study was applied to the analgesic solution and promoted the detection of an unexpected peak in 24 hours. Based on it, further stability studies are necessary to determine the extended stability data.