Stability evaluation of compounded clonidine hydrochloride oral liquids based on a solid-phase extraction HPLC-UV method.

Autor: Coache D; Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada., Friciu M; Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada., Roullin VG; Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada., Boulé M; Sainte-Justine University Hospital Center, Montréal, Québec, Canada., Forest JM; Sainte-Justine University Hospital Center, Montréal, Québec, Canada., Leclair G; Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2021 Nov 30; Vol. 16 (11), pp. e0260279. Date of Electronic Publication: 2021 Nov 30 (Print Publication: 2021).
DOI: 10.1371/journal.pone.0260279
Abstrakt: 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.
Competing Interests: Daphné Coache received an “Accelerate” joint scholarship from Mitacs and Vigilance Santé. Mitacs is a Canadian not-for-profit organization that offers research and training programs. Vigilance Santé develops drug treatment software and databases for front-line health care professionals. As part of the “Accelerate” scholarship program, Daphné Coache performed an internship at Vigilance Santé were she was involved in the update and maintenance of their information database system on compounded formulations. The sponsors did not play any role in the study design, data collection and analysis, decision to publish, nor preparation of this manuscript. The sponsors have no competing interests with regards to this publication. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
Databáze: MEDLINE
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