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

One unknown impurity (degradation product) present at a level below 0.1% in the initial samples increased to a level of 0.5% in 6 M/40 °C/75% RH stability samples of risperidone tablets was detected by gradient reverse-phase high-performance liquid chromatography (HPLC). This impurity was isolated u...

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Veröffentlicht in:	Journal of pharmaceutical and biomedical analysis 2008-01, Vol.46 (1), p.165-169
Hauptverfasser:	Bharathi, Ch, Chary, D. Krishnama, Kumar, M. Saravana, Shankar, Rama, Handa, V.K., Dandala, Ramesh, Naidu, A.
Format:	Artikel
Sprache:	eng
Schlagworte:	Analysis Analytical, structural and metabolic biochemistry Antipsychotic Agents - chemistry Biological and medical sciences Characterization Chromatography, High Pressure Liquid - methods Degradation product Drug Contamination Drug Stability Fundamental and applied biological sciences. Psychology General pharmacology Hot Temperature Isolation Isoxazoles - chemistry Isoxazoles - isolation & purification Light Magnetic Resonance Spectroscopy - methods Mass Spectrometry - methods Medical sciences Models, Chemical Molecular Structure Pharmacology. Drug treatments Preparative HPLC Risperidone Risperidone - analogs & derivatives Risperidone - chemistry Risperidone - isolation & purification Tablets
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Zusammenfassung:	One unknown impurity (degradation product) present at a level below 0.1% in the initial samples increased to a level of 0.5% in 6 M/40 °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-4 H-pyrido[1,2- a] pyrimidin-4-one. Structural elucidation of this impurity by spectral data ( 1H NMR, 13C NMR, DEPT, MS and IR), formation and mechanism has been discussed in detail.
ISSN:	0731-7085 1873-264X
DOI:	10.1016/j.jpba.2007.08.008