A novel ethaselen injection formulation has been developed in our laboratory. The objective of the present study was to establish and validate a high performance liquid chromatography （HPLC） method for the determination of ethaselen in its injection formulation. Analysis was performed on an ODS column with isocratic elution at 40 ℃. Mobile phase was consisted of 0.01% phosphoric acid and methanol （60：40, v/v）. The detection wavelength was set at 320 nm and the flow rate was 1.0 mL/min. The results showed that the calibration curves of ethaselen were linear in the range of 10-50 μg/mL （r2 = 0.9999）. The limit of detection for ethaselen was 100 ng/mL. The average recovery of ethaselen was 100.14%. The labeled content of ethaselen in its injection formulation was in the range of 102%-103% of the measured content. In conclusion, this method was stable and reproducible, thus providing a useful tool for the routine analysis of this novel ethaselen injection formulation.
In the present research, we selected Sylysia as a porous material and febuxostat（FBT） as model drug to prepare the FBT SiO2 solid dispersions using a solvent evaporation method. We firstly established an HPLC method for determining FBT in our prepared FBT SiO2 solid dispersions. And then, the characteristics of FBT SiO2 solid dispersions were investigated, including differential scanning calorimetry（DSC）, powder X-ray diffraction（PXRD）, scanning electron microscope（SEM）, particle size and distribution. The solubility and dissolution of FBT SiO2 solid dispersion were also evaluated. The results of DSC and PXRD showed that the FBT existed in an amorphous state in FBT SiO2 solid dispersions. The SEM and particle size results indicated that the shape and average particle size of FBT SiO2 solid dispersions was similar to the Sylysia. The solubility and dissolution of FBT in FBT SiO2 solid dispersions were significantly enhanced compared with the pure FBT. In conclusion, we successfully prepared FBT SiO2 solid dispersions to increase the solubility and dissolution rate of the poorly water-soluble FBT.
