DEVELOPMENT AND VALIDATION OF THE STABILITY INDICATING LIQUID CHROMATOGRAPHIC METHOD FOR RIFAXIMIN -AN ANTIBIOTIC
Abstract
An isocratic reversed-phase high-performance liquid chromatographic method was developed and validated for the determination of rifaximin. The samples were analyzed by high-performance liquid chromatography (HPLC). Chromatographic separation was achieved on a C18 column using an aqueous tetra butyl ammonium hydrogen sulphate: methanol (10:90, v/v), with flow rate 1.0 mL/min (UV detection at 454 nm). Linearity was observed over the concentration range of 1.0–200 μg/mL with regression equation 15407x +6677 (R2 = 0.9999). The LOQ was found to be 0.786μg/mL and the LOD was found to be 0.238μg/mL. Rifaximin was subjected to stress conditions of degradation in aqueous solutions including acidic, alkaline, oxidation, photolysis and thermal degradation. The forced degradation studies were performed by using HCl, NaOH, H2O2, thermal and UV radiation. Rifaximin is more sensitive towards acidic conditions in comparison to oxidation and very much resistant towards alkaline, thermal and photolytic degradations. The method was validated as per ICH guidelines. The RSD for intra-day (0.28-0.55) and inter-day (0.68-0.81) precision were found to be less than 1 %. The percentage recovery was in good agreement with the labelled amount in the pharmaceutical formulations and the method is simple, specific, precise, robust and accurate for the determination of Rifaximin in pharmaceutical formulations.
DOI
https://doi.org/10.22270/jddt.v3i2.424
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