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

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

Volume: 13 Issue: 6

Author(s): Ana Carolina Kogawa*, Jacqueline Nakau Mendonça, Norberto Peporine Lopes and Hérida Regina Nunes Salgado

Affiliation:

• Faculdade de Ciências Farmacêuticas, UNESP, Rodovia Araraquara-Jaú, km 1, CEP 14801-902, Araraquara, SP,Brazil

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

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.

Cite this article as:

Kogawa Carolina Ana*, Mendonça Nakau Jacqueline, Lopes Peporine Norberto and Nunes Salgado Regina Hérida, Method Indicative of Stability for the Determination of Rifaximin and Its Degradation Products by Thin Chromatographic, Current Pharmaceutical Analysis 2017; 13 (6) . https://dx.doi.org/10.2174/1573412912666160801103712