Pharmaceutical evaluation of carbamazepine modifications: comparative study for photostability of carbamazepine polymorphs by using Fourier-transformed reflection-absorption infrared spectroscopy and colorimetric measurement.
The tablet surface was evaluated without physical damage by means of Fourier-transform infrared reflection-absorption spectroscopy (FT-IR-RAS) and colorimetric measurement (colour difference, delta E) of the carbamazepine polymorphs I, II and III, after photodegradation at two irradiation intensities (3.0 and 12.0 J cm-2s-1) under a near-UV fluorescent lamp. The surface of sample pellets of all crystalline forms turned gradually from white to yellow-orange upon exposure to light, and the discoloration rate of form II was faster than that of forms I and III, indicating that form II was the most unstable of the three. The major photoproducts were identified by HPLC, NMR and MS analyses. The carbamazepine content on the surface of the tablet was determined based on the absorption at 1685 cm-1 attributable to C=O stretch vibration in the FT-IR-RAS spectra before and after irradiation by a near-UV fluorescent lamp. The semilogarithmic plots of the photodegradation profiles of the various polymorphs were straight lines, including the induction period, indicating that degradation of the drug on the surface followed first-order kinetics. The induction periods of all forms were not significantly different. However, the degradation rate constant of form II at 12.0 J cm-2s-1 was 5.1 and 1.5 times larger than those of forms I and III, respectively.
Department of Pharmaceutical Technology, Kobe Pharmaceutical University, Japan.
Y
Y
Matsuda
R
R
Akazawa
R
R
Teraoka
M
M
Otsuka
D002152:Calorimetry, Differential Scanning; D002220:Carbamazepine / Q000031:analogs & derivatives / Q000737:chemistry* / Q000528:radiation effects; D002851:Chromatography, High Pressure Liquid; D003116:Color; D003124:Colorimetry; D004355:Drug Stability; D007536:Isomerism; D007700:Kinetics; D008027:Light; D009682:Magnetic Resonance Spectroscopy; D013058:Mass Spectrometry; D010777:Photochemistry; D017550:Spectroscopy, Fourier Transform Infrared; D013607:Tablets; D014961:X-Ray Diffraction
D013607:Tablets; D002220:Carbamazepine