1. Identification, isolation and characterization of potential degradation product in risperidone tablets.
- Author
-
Bharathi Ch, Chary DK, Kumar MS, Shankar R, Handa VK, Dandala R, and Naidu A
- Subjects
- Antipsychotic Agents chemistry, Chromatography, High Pressure Liquid methods, Drug Stability, Hot Temperature, Isoxazoles isolation & purification, Light, Magnetic Resonance Spectroscopy methods, Mass Spectrometry methods, Models, Chemical, Molecular Structure, Risperidone isolation & purification, Tablets, Drug Contamination, Isoxazoles chemistry, Risperidone analogs & derivatives, Risperidone chemistry
- Abstract
One unknown impurity (degradation product) present at a level below 0.1% in the initial samples increased to a level of 0.5% in 6M/40 degrees C/75% RH stability samples of risperidone tablets was detected by gradient reverse-phase high-performance liquid chromatography (HPLC). This impurity was isolated using reverse-phase preparative liquid chromatography. Based on the spectral data the structure of this impurity is characterized as 3-[2-[4-[6-fluoro-1,3-benzoxazol-2-yl]piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a] pyrimidin-4-one. Structural elucidation of this impurity by spectral data ((1)H NMR, (13)C NMR, DEPT, MS and IR), formation and mechanism has been discussed in detail.
- Published
- 2008
- Full Text
- View/download PDF