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Aripiprazole
Febry Ardiana1, Maria L A D Lestari, Gunawan Indrayanto
1Research & Development, Bernofarm Pharmaceutical Company, Buduran-Sidoarjo, Indonesia.
Summary
Aripiprazole, an atypical antipsychotic, exists in various forms. Analytical techniques like spectroscopy and chromatography are crucial for its identification, impurity analysis, and bioavailability studies, ensuring effective drug formulations.
Area of Science:
- Pharmaceutical Chemistry
- Analytical Chemistry
- Pharmacology
Background:
- Aripiprazole is an atypical antipsychotic belonging to the benzisoxazole derivatives class.
- The drug is available in multiple salt and polymorph forms, necessitating distinct analytical approaches.
- Understanding these forms is critical for consistent therapeutic outcomes.
Purpose of the Study:
- To review analytical methodologies for characterizing aripiprazole polymorphs.
- To highlight methods for analyzing aripiprazole and its impurities.
- To emphasize the importance of bioavailability studies for optimizing aripiprazole formulations.
Main Methods:
- Solid-state characterization using X-ray diffraction, IR spectroscopy, and Differential Scanning Calorimetry (DSC) for polymorph differentiation.
- Chromatographic techniques including High-Performance Thin-Layer Chromatography (HPTLC), High-Performance Liquid Chromatography (HPLC), and Capillary Electrophoresis (CE) for drug and impurity analysis.
- Mass Spectrometry/Mass Spectrometry (MS/MS) coupled with chromatography for metabolite analysis.
Main Results:
- Established spectroscopic and thermal methods effectively distinguish between aripiprazole polymorphs.
- Various instrumental methods are suitable for quantitative analysis of aripiprazole and its related impurities.
- MS/MS detection offers high sensitivity and specificity for metabolite profiling.
Conclusions:
- A combination of analytical techniques is essential for comprehensive characterization of aripiprazole.
- Accurate analysis of aripiprazole, its impurities, and metabolites is vital for drug development and quality control.
- Bioavailability studies of different aripiprazole polymorphs are key to optimizing pharmaceutical dosage forms for improved efficacy.
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