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Method Indicative of Stability for the Determination of Rifaximin and Its Degradation Products by Thin Chromatographic

[ Vol. 13 , Issue. 6 ]

Author(s):

Ana Carolina Kogawa*, Jacqueline Nakau Mendonça, Norberto Peporine Lopes and Hérida Regina Nunes Salgado   Pages 520 - 524 ( 5 )

Abstract:


Introduction: Rifaximin is an oral antimicrobial, intestine-selective and non systemic with adverse effects compared to placebo.

Materials and Methods: Rifaximin, until then, does not have standardized analytical methods in most official compendia. Fast, economic, environmentally friendly and selective method indicative of stability by thin chromatographic (TC) for the determination of rifaxmin and its degradation products was designed. The TC method used silica gel as stationary phase and ethyl acetate: ethyl alcohol, 90:10 (v/v), as mobile phase to achieve spots for rifaximin (Rf=0.62) and its degradation products basic (Rf=0.33, 0.49, 0.56), acidic (Rf=0.47, 0.54), oxidative (Rf=0.28) and neutral (Rf=0.32). The plates were visualized in chamber UV at 254 nm. Simultaneously, analysis of high performance liquid chromatography (HPLC) was performed using Eclipse Plus C18 (150 mm x 4.6 mm) column and purified water + 0.1 % glacial acetic acid and ethanol in the ratio 52:48 (v/v) as mobile phase at 290 nm. The objective was to verify the interchangeability of TLC and HPLC methods in obtaining the degradation products of rifaximin tablets. In HPLC, as in TC was observed the rifaximin (RT=5.5) and its degradation products acidic, basic (RT =4.2 and 4.7), oxidative (RT =3.6 min) and neutral (RT =4.7 min).

Conclusion: These techniques can be used as methods indicative of stability because they identify the rifaximin and its degradation products. Therefore, they can be effectively applied in quality control of rifaximin in tablets. The study of alternative methods should be encouraged by reducing costs, allowing the use of environmentally friendly solvents, optimize analysts and equipment while providing quality analyses.

Keywords:

Rifaximin, degradation products, HPLC, stability, tablets, thin chromatography.

Affiliation:

Faculdade de Ciências Farmacêuticas, UNESP, Rodovia Araraquara-Jaú, km 1, CEP 14801-902, Araraquara, SP, Center for Research in Natural and Synthetic Products, Department of Physics and Chemistry, School of Pharmaceutical Sciences of Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, Center for Research in Natural and Synthetic Products, Department of Physics and Chemistry, School of Pharmaceutical Sciences of Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, Department of Drugs and Pharmaceutics, School of Pharmaceutical Sciences, Univ Estadual Paulista - UNESP, Araraquara, São Paulo

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