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Risperidone is a widely used atypical antipsychotic acting primarily through antagonism of dopamine D₂ and serotonin 5-HT₂ receptors, indicated for the treatment of schizophrenia, bipolar disorder, and related psychiatric conditions.1 Cleaning validation is a critical requirement in pharmaceutical manufacturing to prevent cross-contamination and ensure patient safety. This study focuses on the optimization of the swabbing procedure and HPLC conditions for risperidone cleaning validation.
A key aspect of swab method development is the selection of an appropriate extraction medium that ensures high and reproducible recovery from equipment surfaces. Due to its potency, even trace residues of risperidone may lead to cross-contamination; therefore, sensitive and reliable analytical methods are required for its quantification in cleaning validation studies.
Risperidone is a weak base with pH-dependent solubility and significantly higher solubility under acidic conditions. In this study, recovery efficiency was evaluated using methanol and phosphoric acid–acidified methanol as swabbing media. The acidified medium significantly improved desorption from the swab matrix, achieving recoveries above the 80% acceptance criterion,² whereas unacidified methanol showed lower recovery.
The analysis was performed using a validated HPLC method optimized for cleaning validation. Improved separation of risperidone from adjacent peaks was achieved by increasing the proportion of inorganic mobile phase in combination with acetonitrile, which provided better resolution compared to methanol-based systems.
In conclusion, the use of an acidified extraction medium ensures robust and reproducible recovery, while the optimized HPLC method provides accurate and reliable quantification suitable for routine cleaning validation in risperidone manufacturing.