A Clean, Sustainable and Stability-Indicating Method for the Quantification of Ceftriaxone Sodium in Pharmaceutical Product by HPLC

化学 头孢曲松 色谱法 高效液相色谱法 降级(电信) 有机化学 生物化学 计算机科学 电信 抗生素
作者
Mariana Teixeira da Trindade,Ana Carolina Kogawa,Hérida Regina Nunes Salgado
出处
期刊:Journal of Chromatographic Science [Oxford University Press]
卷期号:60 (3): 260-266 被引量:10
标识
DOI:10.1093/chromsci/bmab078
摘要

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.

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