Open AccessStability evaluation of compounded clonidine hydrochloride oral liquids based on a solid-phase extraction HPLC-UV method
Author(s) -
Daphné Coache,
Mihaela Friciu,
Gaëlle Roullin,
Marianne Boulé,
JeanMarc Forest,
Grégoire Leclair
Publication year - 2021
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0260279
Subject(s) - extraction (chemistry) , chromatography , high performance liquid chromatography , hydrochloride , clonidine , solid phase extraction , chemical stability , materials science , chemistry , organic chemistry , medicine , anesthesia
The present study aimed to assess the stability of clonidine hydrochloride oral liquids (20-μg/mL) prepared from two different generic tablets in Ora-Blend and stored in amber plastic bottles. Physical and chemical stabilities were evaluated over a period of 90 days at 25°C. Analytical challenges were overcome with the development of a new extraction procedure based on solid phase extraction to ensure efficient clonidine hydrochloride quantification. The absence of physical instabilities, evaluated by qualitative and quantitative measurements (static multiple light scattering), as well as the absence of chemical instabilities, evidenced by a stability-indicating HPLC-UV method, confirmed that a beyond-use date of 90 days was appropriate for these compounded oral liquids.