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Published on: June 10, 2021
Chemical stability of perphenazine
1Pharmaceutics Division, University of Houston, Houston, Texas.
International Journal of Pharmaceutical Compounding
|August 9, 2013
Summary
Perphenazine oral liquid stability was assessed using a new HPLC method. The study recommends a 30-day beyond-use date for perphenazine liquid dosage forms due to stability limitations.
Area of Science:
- Pharmaceutical Sciences
- Analytical Chemistry
Background:
- Perphenazine is an antipsychotic medication.
- Ensuring the stability of oral liquid dosage forms is crucial for therapeutic efficacy and patient safety.
Purpose of the Study:
- To evaluate the stability of perphenazine in oral liquid dosage forms.
- To develop and validate a stability-indicating high-performance liquid chromatography (HPLC) assay method for perphenazine.
Main Methods:
- Development and validation of a stability-indicating HPLC assay method.
- Assay method demonstrated a linear relationship (r=0.998) between peak heights and concentrations.
- Method showed high precision (0.6% relative standard deviation) and specificity, unaffected by decomposition products or excipients.
Main Results:
- Perphenazine oral liquid dosage forms exhibited limited stability, with a beyond-use date of only 30 days under room temperature storage in amber bottles.
- The pH remained stable at 3.7, and physical appearance did not change over 90 days.
- The developed HPLC method proved reliable for stability studies.
Conclusions:
- A 30-day beyond-use date is recommended for perphenazine oral liquid dosage forms.
- The developed stability-indicating HPLC method is suitable for routine stability testing of perphenazine formulations.
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