Identification, isolation and characterization of potential degradation product in risperidone tablets.

Authors :: Bharathi Ch
Chary DK
Kumar MS
Shankar R
Handa VK
Dandala R
Naidu A
Source :: Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2008 Jan 07; Vol. 46 (1), pp. 165-9. Date of Electronic Publication: 2007 Aug 14.
Publication Year :: 2008
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.

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

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