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

Area of Science:

• Pharmaceutical Sciences
• Drug Stability
• Compounding Pharmacy

Background:

• Clonidine hydrochloride is used to treat various conditions.
• Stability of compounded oral liquids is crucial for patient safety and therapeutic efficacy.
• Generic formulations may exhibit different stability profiles compared to brand-name drugs.

Purpose of the Study:

• To evaluate the physical and chemical stability of clonidine hydrochloride oral liquids.
• To determine an appropriate beyond-use date for compounded clonidine hydrochloride oral liquids.
• To assess the stability of formulations prepared from different generic clonidine hydrochloride tablets.

Main Methods:

• Preparation of clonidine hydrochloride oral liquids (20-μg/mL) in Ora-Blend from two generic tablets.
• Storage in amber plastic bottles at 25°C for 90 days.
• Physical stability assessment using static multiple light scattering.
• Chemical stability assessment using a stability-indicating HPLC-UV method.
• Development of a novel solid-phase extraction method for accurate quantification.

Main Results:

• No physical instabilities were observed during the 90-day study period.
• Chemical stability was maintained, as evidenced by the HPLC-UV analysis.
• The developed extraction procedure ensured efficient and reliable clonidine hydrochloride quantification.
• Both formulations demonstrated consistent stability profiles.

Conclusions:

• A beyond-use date of 90 days is appropriate for compounded clonidine hydrochloride oral liquids prepared from the studied generic tablets.
• The compounded oral liquids maintained both physical and chemical integrity under the tested conditions.
• The findings support the safe use of these compounded medications within the established beyond-use date.