Background: A simple, eco-friendly and low-cost Infrared (IR) method was developed and validated for the analysis of Cefepime Hydrochloride (CEF) in injectable formulation. Different from some other methods, which employ organic solvents in the analyses, this technique does not use these types of solvents, removing large impacts on the environment and risks to operators.

Objective: This study aimed at developing and validating a green analytical method using IR spectroscopy for the determination of CEF in pharmaceutical preparations.

Methods: The method was validated according to ICH guidelines and the quantification of CEF was performed in the spectral region absorbed at 1815-1745 cm-1 (stretching of the carbonyl group of β- lactam ring).

Results: The validated method showed to be linear (r = 0.9999) in the range of 0.2 to 0.6 mg/pellet of potassium bromide, as well as for the parameters of selectivity, precision, accuracy, robustness and Limits of Detection (LOD) and Quantification (LOQ), being able to quantify the CEF in pharmaceutical preparations. The CEF content obtained by the IR method was 103.86%.

Conclusion: Thus, the method developed may be an alternative in the quality control of CEF sample in lyophilized powder for injectable solution, as it presented important characteristics in the determination of the pharmaceutical products, with low analysis time and a decrease in the generation of toxic wastes to the environment.

背景：开发了一种简单，环保且低成本的红外（IR）方法，并已验证可用于注射剂中盐酸头孢吡肟（CEF）的分析。与其他在分析中使用有机溶剂的方法不同，该技术不使用这些类型的溶剂，从而消除了对环境的巨大影响和对操作人员的风险。

目的：本研究旨在开发和验证使用红外光谱法测定药物制剂中CEF的绿色分析方法。

方法：根据ICH指南验证了该方法的有效性，并在1815-1745 cm-1处吸收的光谱区域（拉伸β-内酰胺环的羰基）对CEF进行了定量。

结果：经验证的方法显示为线性（r = 0.9999），范围为0.2至0.6 mg /粒溴化钾，以及选择性，精密度，准确性，鲁棒性和检测限（LOD）和定量（LOQ），能够定量药物制剂中的CEF。通过IR法得到的CEF含量为103.86％。

结论：因此，所开发的方法可能是可注射溶液冻干粉中CEF样品质量控制的替代方法，因为它在药物产品的测定中具有重要的特征，分析时间短并且减少了毒物的产生浪费到环境。