Ceftriaxone sodium is a widely used antimicrobial, which is only available as a lyophilized powder. The presence of methods for evaluating the quality of this product is very important and helps to ensure its effectiveness, in addition to contributing to the fight against bacterial resistance. Therefore, a clean and sustainable high-performance liquid chromatography (HPLC) method has been developed for evaluating ceftriaxone stability in pharmaceutical product. A Zorbax SB C18 (150 × 4.6 mm, 5 μm) column was maintained at 25°C; the mobile phase consisted of purified water acidified with 0.2% orthophosphoric acid and ethanol (87: 13, v/v) at a flow rate of 0.9 mL min−1. The detection wavelength was set at 260 nm. The method was linear over a concentration range of 20–120 μg mL−1, precise with relative standard deviations <2%, robust in the event of minor changes to the original method conditions, accurate with recovery between 98% and 102% and specific to degradation products. The retention time for ceftriaxone sodium was ~4.6 minutes. This work shows an ecologically correct option by HPLC method for the evaluation of ceftriaxone sodium in pharmaceutical product, as well as its stability, which addresses the requirements of the current green and sustainable analytical chemistry.

中文翻译：

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高效液相色谱法定量药品中头孢曲松钠的清洁、可持续和稳定性指示方法

头孢曲松钠是一种广泛使用的抗菌剂，只能以冻干粉的形式获得。除了有助于对抗细菌耐药性外，评估该产品质量的方法非常重要，有助于确保其有效性。因此，开发了一种清洁且可持续的高效液相色谱 (HPLC) 方法来评估医药产品中的头孢曲松稳定性。Zorbax SB C18 (150 × 4.6 mm, 5 μm) 色谱柱保持在 25°C；流动相由用 0.2% 正磷酸和乙醇 (87:13, v/v) 酸化的纯净水组成，流速为 0.9 mL min-1。检测波长设置为 260 nm。该方法在 20–120 μg mL-1 的浓度范围内呈线性，相对标准偏差 <2%，精确，在原始方法条件发生微小变化的情况下具有稳健性，准确度在 98% 和 102% 之间，并且对降解产物具有特异性。头孢曲松钠的保留时间约为 4.6 分钟。这项工作显示了通过 HPLC 方法评估医药产品中的头孢曲松钠及其稳定性的生态正确选择，满足了当前绿色和可持续分析化学的要求。