HYDRATE TRANSFORMATION OF SODIUM SULFACETAMIDE AND NEOMYCIN SULPHATE
Objective: Hydrate transformation influence physical properties of the active pharmaceutical ingredients (APIs) such as solubility and stability. This research aimed to analyzed the hydrate transformation of sodium sulfacetamide and neomycin sulphate after grinding and storing the ground materials in the high humidity, using FTIR. The analysis supported by the other common solid characterization instruments, such as: Differential Thermal Analysis (DTA), Differential Scanning Calorimetryâ€“Thermal Gravimetry Analysis (DSC-TGA), Karl Fischer Titration (KFT) and Powder X-Ray Diffraction (PXRD).
Methods: Hydrate tgransformation usually is studied using common solid analysis instruments: DTA, DSC-TGA, (KFT) and PXRD. The FTIR commonly is used as qualitative methods for analyse the hydrates. In this research; the instrument, was tried to be used to evaluate hydrate transformation of sodium sulfacetamide and neomycin sulphate after grinding and storing in the high humidity, quantitatively; due to its simplicity and availability widely. Firstly, the raw material of sodium sulfacetamide and neomycin sulphate were characterized by FTIR, besides DTA-DSC, PXRD, and KFT. Using FTIR, the hydrateâ€™s vibration spectra of both antibiotics was determined qualitative and quantitatively. The calibration curves were composed from a series of each antibiotic concentrations in KBr plats, then AUC (area under the curve) of derivative spectra was plotted against the concentrations. Next, the antibiotics were ground and sampled periodically, then that were measured with FTIR. Ground samples afterward were stored in the humidity (71 and 99% RH). Data collected were used to analyze the hydrate change/transformation, which were confirmed with thermal analysis (DTA-TGA-DSC), KFT, and PXRD.
Results: The hydrate spectra water of sodium sulfacetamide was observed at 3382â€“3455 cm-1 clearly, but neomycin sulphate hydrate spectra could not be seen clearly. This phenomenon predicted was caused by its high hygroscopic properties, which brought much water covered the compound surface then disturbed the measurement. Thermogram and KFT result showed that sodium sulfacetamide and neomycin sulphate lost their hydrate after 180 min grinding, but after storage in 71 and 99 % RH, the hydrates were restored back. The diffractogram showed the change of ground neomycin sulphate from amorphous became to crystalline.
Conclusion: Based on the data, FTIR can be used as a proper alternative method or complementary analysis instrument for hydrate transformation for sodium sulfacetamide after grinding and storing in the high humidity, but cannot be applied to neomycin sulphate because of its high hygroscopicity. There were not changes of sodium sulfacetamide after ground and stored in high humidity, meanwhile neomycin sulphate changed from amorphous became to a crystalline.
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