Stability of diclofenac sodium in the inclusion complex with beta-cyclodextrin in the solid state.
The aim of this study was to characterize the thermal stability of diclofenac sodium both alone and in the inclusion complex with beta-cyclodextrin in the solid state, by determination of the number of the products of its decomposition, which were identified by GC-MS. The molar ratio of diclofenac sodium in the inclusion complex with beta-cyclodextrin was 1:1. The decomposition of diclofenac sodium both alone and in inclusion complex with beta-cyclodextrin occurred according to the first-order reaction. The HPLC of the samples thermostated at 80 degrees C gave five products of decomposition, which were identified by GC-MS. Diclofenac sodium in the inclusion complex with beta-cyclodextrin was more thermally stable. Thermal decomposition of diclofenac sodium leads to formation of five products, of which 4-chloro-10H-9-acridinone had not been reported previously in the literature.
Cwiertnia
B
B
Department of Inorganic and Analytical Chemistry, Karol Marcinkowski University of Medical Sciences, Poznan, Poland.
Hladon
T
T
Stobiecki
M
M
D002152:Calorimetry, Differential Scanning; D002851:Chromatography, High Pressure Liquid; D003505:Cyclodextrins / Q000737:chemistry*; D004008:Diclofenac / Q000737:chemistry*; D004355:Drug Stability; D005079:Excipients / Q000737:chemistry*; D008401:Gas Chromatography-Mass Spectrometry; D006358:Hot Temperature; D007700:Kinetics; D009682:Magnetic Resonance Spectroscopy; D013816:Thermodynamics; D014961:X-Ray Diffraction; D047392:beta-Cyclodextrins
D003505:Cyclodextrins; D005079:Excipients; D047392:beta-Cyclodextrins; D004008:Diclofenac; C031215:betadex