PEMBUATAN GARAM LEVOFLOKSASIN DENGAN ASAM FLUFENAMAT DAN ASAM NILUMAT METODE RAMAH LINGKUNGAN DAN PENETAPAN KADARNYA DENGAN UV DERIVATIF
Pharmaceutical salt production is frequently utilised to improve the physicochemical properties of drug substances. Recently, a screening has been done for the formation of levofloxacin-flufenamate (LF) and levofloxacin-niflumate (LN) salts at a molar ratio of 1:1. These salts are made using solvent...
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| Format: | Final Project |
| Language: | Indonesia |
| Online Access: | https://digilib.itb.ac.id/gdl/view/82369 |
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| Institution: | Institut Teknologi Bandung |
| Language: | Indonesia |
| Summary: | Pharmaceutical salt production is frequently utilised to improve the physicochemical properties of drug substances. Recently, a screening has been done for the formation of levofloxacin-flufenamate (LF) and levofloxacin-niflumate (LN) salts at a molar ratio of 1:1. These salts are made using solvent evaporation method which takes a considerable amount of time. The aim of this research is to create LF and LN salts using the solvent dropped grinding (SDG) technique to overcome the shortcomings of evaporation technique, which will subsequently be characterised by electrothermal analysis, TG/DTA, PXRD, and FTIR. In addition to that, the stability of these salts were observed through visual and instrumental methods utilizing Powder X-Ray Diffraction (PXRD) and Fourier Transmitan Infra Red (FTIR). Chemically, the determination is done using a previously validated derivative UV-spectrophotometry method. The results of this study show that the SDG method can produce homogenous LF and LN salts in larger quantity, more rapidly, and with very minimal solvent. LF has a melting temperature of 172,7 C with diffraction peaks at 2? = 5, 7, 8, 17, and 22 ?, while LN shows a melting temperature of 190,8 C with diffraction peaks at 2?= 4, 7, 9, 13, 16, 17, and 19 ?. Additionally, FTIR spectra confirmed the formation of methylamine piperazine bonds with carboxylic groups; this is in accordance with the results of screening using the solvent evaporation technique reported previously. Moreover, a validated assay method using derivative UV spectrophotometry was successfully developed and provided absorbance readings at 346, 220, and 220 nm for levofloxacin, flufenamic acid, and niflumic acid. Furthermore, stability tests using room temperature (25 ± 3 ?C) and humidity (75 ± 5% RH) during a four-week period of open storage showed that both LF and LN salts were more stable than single compound. Hence, these two salts could potentially be developed further.
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