Stability of haloperidol in 5% dextrose injection

Area of Science:

• Pharmaceutical Chemistry
• Analytical Chemistry

Background:

• Haloperidol is an antipsychotic medication.
• Assessing the stability of injectable formulations is crucial for clinical use.
• Existing methods may not fully characterize drug product stability.

Purpose of the Study:

• To evaluate the stability of haloperidol in 5% dextrose injection.
• To validate a high-pressure liquid chromatographic (HPLC) method for haloperidol quantification.
• To compare the HPLC method with existing procedures.

Main Methods:

• Prepared haloperidol solutions (10 mg/dL) in 5% dextrose injection.
• Stored solutions at 24°C in amber glass bottles and plastic bags.
• Assayed solutions using HPLC at multiple time points (0, 1, 7, 14, 38 days).
• Verified HPLC accuracy using various commercial haloperidol dosage forms.

Main Results:

• Haloperidol showed no loss of potency over 38 days under tested conditions.
• Substantial loss of methylparaben and propylparaben observed in plastic bag storage.
• HPLC assay accurately quantified haloperidol and detected paraben degradation.
• Oxidation products did not interfere with haloperidol quantification.

Conclusions:

• Haloperidol 10 mg/dL in 5% dextrose injection is stable for at least 38 days.
• The developed HPLC method is accurate and provides stability data beyond simple potency.
• HPLC offers advantages over USP-NF procedures for comprehensive stability assessment.