B. Cwiertnia et al., Stability of diclofenac sodium in the inclusion complex with beta-cyclodextrin in the solid state, J PHARM PHA, 51(11), 1999, pp. 1213-1218
The aim of this study was to characterize the thermal stability of diclofen
ac 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 dec
omposition, which were identified by GC-MS.
The molar ratio of diclofenac sodium in the inclusion complex with beta-cyc
lodextrin was 1:1. The decomposition of diclofenac sodium both alone and in
inclusion complex with beta-cyclodextrin occurred according to the first-o
rder reaction. The HPLC of the samples thermostated at 80 degrees C gave fi
ve 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 forma
tion of five products, of which 4-chloro-10H-9-acridinone had not been repo
rted previously in the literature.