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

PLoS One. 2021 Nov 30;16(11):e0260279. doi: 10.1371/journal.pone.0260279. eCollection 2021.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Chromatography, High Pressure Liquid
  • Clonidine / chemistry*
  • Drug Evaluation
  • Solid Phase Extraction
  • Spectrophotometry, Ultraviolet

Substances

  • Clonidine

Grants and funding

The authors gratefully acknowledge Vigilance Santé and Mitacs for their financial support. 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.