Rifaximin, an antimicrobial used for the treatment of various diseases, lacks analytical methods in official compendia for evaluation of the final product. This paper presents an eco-friendly protocol for rifaximin tablets by high performance liquid chromatography coupled with mass spectrometry (HPLC-MS). The method was completely validated according to the International Conference on Harmonization guidelines and developed following the concept of Quality by Design. The separation was achieved using a C18 column, purified water +0.1% glacial acetic acid and ethyl alcohol, 52:48 (v/v), as mobile phase, 0.9 mL min−1 at 290 nm and ambient room temperature. Mass spectral analyses were performed using electrospray ionization (ESI) ion source and ion trap mass analyzer. The method was linear over the concentration range of 5–50 μg mL−1. The sample was subjected to acidic, basic, neutral, oxidative and photolytic degradation. Degradation products did not interfere in the quantification of the rifaximin, so the method can be considered indicative of stability. Degradation products were also evaluated individually by microbiological method using Escherichia coli. The validated method could be used promisingly as green analytical strategies for detection and quantification of rifaximin in tablets.

中文翻译：

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通过 HPLC-MS 和微生物比浊法对片剂中的利福昔明进行环保药物分析

利福昔明是一种用于治疗各种疾病的抗菌剂，官方药典中缺乏用于评估最终产品的分析方法。本文通过高效液相色谱与质谱联用 (HPLC-MS) 提出了一种环保的利福昔明片剂方案。该方法已根据国际协调会议指南进行了完全验证，并按照质量源于设计的概念进行开发。使用 C18 色谱柱、纯化水 + 0.1% 冰醋酸和乙醇，52:48 (v/v) 作为流动相，在 290 nm 和环境室温下为 0.9 mL min-1 实现分离。使用电喷雾电离 (ESI) 离子源和离子阱质量分析仪进行质谱分析。该方法在 5–50 μg mL-1 的浓度范围内呈线性。样品经受酸性、碱性、中性、氧化和光解降解。降解产物不会干扰利福昔明的定量，因此该方法可以被认为是稳定性的指标。还使用大肠杆菌通过微生物学方法对降解产物进行了单独评估。经验证的方法有望用作检测和定量片剂中利福昔明的绿色分析策略。