Departamento de Farmácia, Universidade Federal do Ceará, FFOE, Rua Cap. Francisco Pedro, 1210, Rodolfo Teófilo, CEP 60430-370 Fortaleza, CE, Brazil.
Talanta. 2010 Aug 15;82(3):918-22. doi: 10.1016/j.talanta.2010.05.056. Epub 2010 Jun 2.
Linezolid (LNZ) is one of the first commercially available (and most widely used) oxazolidinone antibiotics. This study describes the development and validation of a microbiological assay, applying the cylinder-plate method, for the determination of the antibiotic linezolid, as well as the evaluation of the ability of the method in determining the stability of linezolid in tablets. The validation method yielded good results and included linearity, precision, accuracy, robustness and selectivity. The assay is based on the inhibitory effect of LNZ upon the strain of Bacillus subtilis ATCC 9372 used as the test microorganism. The results of the assay were treated statistically by analysis of variance (ANOVA) and were found to be linear (r(2)=0.9998) in the range of 20-80 microg mL(-1), precise (inter-assay: R.S.D.=0.61) and accurate (R.S.D.=1.7). The method developed and validated proved to be indicative of stability and capable of determining the decay of linezolid in the presence of photodegradation products. Comparison of bioassay and liquid chromatography by ANOVA showed no significant difference between methodologies. The results demonstrated the validity of the proposed bioassay, which is a simple and useful alternative methodology for LNZ determination in routine quality control.
利奈唑胺（LNZ）是首批市售（也是应用最广泛）的噁唑烷酮类抗生素之一。本研究描述了一种微生物学检测法的开发和验证，该方法采用了杯碟法，用于测定抗生素利奈唑胺，以及评估该方法在测定片剂中利奈唑胺稳定性方面的能力。验证方法取得了良好的结果，包括线性、精密度、准确度、稳健性和选择性。该检测法基于 LNZ 对枯草芽孢杆菌 ATCC 9372 菌株的抑制作用，枯草芽孢杆菌 ATCC 9372 菌株被用作测试微生物。通过方差分析（ANOVA）对检测结果进行了统计学处理，结果表明，在 20-80 μg/mL 范围内具有良好的线性（r²=0.9998），精密度（日内：RSD=0.61）和准确度（RSD=1.7）良好。所开发和验证的方法表明其具有稳定性，并能够在存在光降解产物的情况下测定利奈唑胺的衰减。通过 ANOVA 对生物测定法和液相色谱法进行比较，两种方法之间没有显著差异。结果证明了所提出的生物测定法的有效性，这是一种用于常规质量控制中利奈唑胺测定的简单而有用的替代方法。
