Faculdade Pitágoras - Campus Poços de Caldas, Av. João Pinheiro, 1046, Poços de Caldas -MG 37701-014, Brazil.
Department of Drugs and Medicines, Faculty of Pharmaceutical Sciences, Universidade Estadual Paulista "Júlio de Mesquita Filho", Araraquara14800-901, SP, Brazil.
Pathogens. 2014 Jul 30;3(3):656-66. doi: 10.3390/pathogens3030656.
The cefuroxime sodium is a second generation cephalosporin indicated for infections caused by Gram-positive and Gram-negative microorganisms. Although this drug is highly studied and researched regarding the antimicrobial activity, pharmacokinetics and pharmacodynamics, there are few studies regarding the development of analytical methodology for this cephalosporin. Thus, research involving analytical methods is essential and highly relevant to optimize its analysis in the pharmaceutical industry and guarantee the quality of the product already sold. This study describes the development and validation of a microbiological assay applying the turbidimetric method for the determination of cefuroxime, using Micrococcus luteus ATCC 9341 as micro-organism test and 3x3 parallel line assay design, with nine tubes for each assay, as recommended by the Brazilian Pharmacopoeia. The developed and validated method showed excellent results of linearity, seletivity, precision and robustness, in the concentration range from 30.0 to 120.0 mg/mL, with 100.21% accuracy and content 99.97% to cefuroxime sodium in injectable pharmaceutical form.
头孢呋辛钠是第二代头孢菌素，用于治疗革兰氏阳性菌和革兰氏阴性菌引起的感染。尽管该药物在抗菌活性、药代动力学和药效学方面进行了大量研究，但关于该头孢菌素分析方法开发的研究却很少。因此，涉及分析方法的研究对于优化其在制药行业中的分析和保证已销售产品的质量至关重要。本研究描述了一种微生物测定法的开发和验证，该方法应用比浊法测定头孢呋辛，使用藤黄微球菌 ATCC 9341 作为微生物测试和 3x3 平行线测定设计，每个测定用 9 个管，如巴西药典所建议。所开发和验证的方法在 30.0 至 120.0mg/mL 的浓度范围内显示出良好的线性、选择性、精密度和稳健性，头孢呋辛钠注射剂的准确度为 100.21%，含量为 99.97%。
