Stability of Extemporaneously Prepared Enalapril Maleate Suspensions in Glass Bottles and Plastic Syringes

Friciu, Mihaela; Zaraa, Sarra; Leclair, Grégoire

doi:10.4212/cjhp.v69i6.1616

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2021

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“…Even though the sample preparation presented in this article is complex and involves a multi-step preparation, results and variations observed are within the acceptable range for the stability evaluation of compounded preparation [ 23 – 27 ]. The advantage of this method is the opportunity to concentrate the analyte to facilitate its detection and to drastically reduce the quantity of excipients injected in the HPLC system.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2021

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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.

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Section: Discussionmentioning

confidence: 99%