EFFECT OF SOLVENT COMPOSITION ON THE STRUCTURE AND STABILITY OF LEVOFLOXACINE-DICLOFENAC SALT
The preparation of levofloxacin-diclofenac salt (LD) with a 1:1 molar ratio has been reported to enhance the solubility, stability, and potential of levofloxacin. However, during the isolation process, several diffractogram forms were observed, potentially due to variations in the solvents used. Thi...
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| Format: | Final Project |
| Language: | Indonesia |
| Online Access: | https://digilib.itb.ac.id/gdl/view/82652 |
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| Institution: | Institut Teknologi Bandung |
| Language: | Indonesia |
| Summary: | The preparation of levofloxacin-diclofenac salt (LD) with a 1:1 molar ratio has been reported to enhance the solubility, stability, and potential of levofloxacin. However, during the isolation process, several diffractogram forms were observed, potentially due to variations in the solvents used. This study aimed to investigate the effect of solvent composition on the preparation of LD salt, characterize and establish the most stable solid form, develop a derivative UV spectrophotometric method for quantification, and assess the stability of LD salt. LD salt was prepared using the Solvent Drop Grinding (SDG) method with methanol and ethanol solvents in varying concentrations of 70%, 95%, and 99%. The resulting salts were characterized by electrothermal analysis, Powder X-ray diffractometer (PXRD), Fourier Transform Infrared Spectroscopy (FTIR), and Differential Thermal Analysis/Thermographic Analysis (DTA/TG). A derivative UV spectrophotometric method was developed for quantification, and stability studies were conducted over four weeks. The result showed three solid forms of LD salt with distinct diffractograms, infrared spectra, and DTA/TG profiles, but similar melting points of ~140-141°C. The first phase was identified as methanolate with methanol release temperature of ~72°C; the second was ethanolate with ethanol release temperature of ~80°C; both forms were produced from SDG with 99% solvents. The last phase was identified as LD with a total solvent release temperature of 100°C, indicating hydrate form obtained from SDG with 70% and 95% solvents and exhibiting the highest stability. The overall data leads to the most practical and environmentally friendly method for producing LD salt, which is grinding with the addition of pure water. Furthermore, it has also been proven that LD salt exhibited better stability compared to single LF, both physically and chemically. Consequently, careful selection of solvent composition is crucial during the isolation of pharmaceutical raw materials, in this case LD salt.
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