Solid State Compatibilty Studies between Budesonide with Some Excipients by using HPLC
Abstract
Compatibility studies are essential for preformulation studies of formulation development. In the present study, HPLC method used for the investigation and to determine the possible interactions between Budesonide and some excipients like sugar spheres , Ethyl cellulose (Aquacoat ECD 30), acetyl tributyl citrate (ATBC), Methacrylic acid copolymer C dispersion (Eudrgit L30D55), triethyl citrate (TEC), polysorbate 80 and talc when stored in elevated temperature conditions. The drug and excipient binary mixtures were evaluated by examining the pure Budesonide or Budesonide-excipient powder mixtures which were stored under different conditions (40°C/75%RH & 25°C/60%RH after 30 days) using High Performance Liquid Chromatography(HPLC). The results demonstrate the suitability of Budesonide with sugar spheres , Ethyl cellulose (Aquacoat ECD 30), acetyl tributyl citrate (ATBC), Methacrylic acid copolymer C dispersion (Eudrgit L30D55), triethyl citrate (TEC), polysorbate 80 and talc when stored in elevated temperature conditions.
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