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Stability studies and structural characterization of pramipexole.
Marta Łaszcz1, Kinga Trzcińska, Marek Kubiszewski
1Pharmaceutical Research Institute, Rydygiera 8, Warsaw, Poland. m.laszcz@ifarm.waw.pl
Journal of Pharmaceutical and Biomedical Analysis
|July 27, 2010
Summary
Pramipexole dihydrochloride absorbs water and forms a monohydrate under typical storage conditions. Structural analysis confirmed the monohydrate
Area of Science:
- Pharmaceutical Sciences
- Solid-State Chemistry
Background:
- Pramipexole dihydrochloride is a medication used to treat Parkinson's disease and restless legs syndrome.
- Understanding the solid-state properties of active pharmaceutical ingredients (APIs) is crucial for drug formulation and stability.
Purpose of the Study:
- To investigate the stability of pramipexole dihydrochloride under various temperature and humidity conditions.
- To characterize the structural changes and identify any new solid forms, specifically the monohydrate.
Main Methods:
- Stability studies conducted at 25°C/60% RH and 40°C/75% RH.
- Analytical techniques including infrared spectroscopy, X-ray powder diffraction, thermogravimetry, nuclear magnetic resonance, and X-ray single crystal diffraction were employed.
Main Results:
- Pramipexole dihydrochloride demonstrated a tendency towards water sorption and monohydrate formation.
- Structural characterization confirmed the formation of pramipexole dihydrochloride monohydrate.
- The monohydrate was found to crystallize in the orthorhombic system within the P212121 space group.
Conclusions:
- Pramipexole dihydrochloride is susceptible to hydration, forming a stable monohydrate under common storage conditions.
- Knowledge of this solid-state transformation is essential for ensuring the quality and efficacy of pramipexole dihydrochloride formulations.
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