Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada.
Sainte-Justine University Hospital Center, Montréal, Québec, Canada.
PLoS One. 2021 Nov 30;16(11):e0260279. doi: 10.1371/journal.pone.0260279. eCollection 2021.
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.
本研究旨在评估两种不同通用片剂制备的 20-μg/mL 盐酸可乐定口服液（Ora-Blend 储存于琥珀色塑料瓶）的稳定性。在 25°C 下，对其进行为期 90 天的物理和化学稳定性评估。通过基于固相萃取的新提取程序开发克服了分析挑战，以确保对盐酸可乐定进行有效定量。通过定性和定量测量（静态多重光散射）评估无物理不稳定性，以及通过稳定性指示 HPLC-UV 方法证明无化学不稳定性，证实这些配制的口服液的有效期超过 90 天是合适的。
