Department of Pharmaceutical Analysis, SRM College of Pharmacy, SRM Institute of Science and Technology, Kancheepuram, Tamil Nadu, India.
Crit Rev Anal Chem. 2020;50(2):179-188. doi: 10.1080/10408347.2019.1599709. Epub 2019 Apr 8.
Bacterial resistance to antibiotics is a growing phenomenon in the world. Considering the relevance of antimicrobials for population and the reduction in the registration of new antimicrobials by regulatory agencies, proper quality control is required to minimize the spread of bacterial resistance and ensure the effectiveness of a treatment, as well as safety for the patient. The recent addition to the antimicrobial world is the oxazolidinone classes of antibiotics, especially useful to treat infections caused by Gram-positive bacteria. Eperezolid and linezolid (LIN) are the two members of the oxazolidinone class of antibiotics. LIN was the first oxazolidinone approved by the Food and Drug Administration. The present review focuses on the analytical methods for the assessment of LIN in pharmaceuticals and biological matrices. The critical validation parameters like the linearity, limit of detection, limit of quantification are discussed for the individual method. Also the critical quality attributes like the sensitivity and the sample preparation techniques for bioanalytical methods are also discussed. Furthermore, some future trends that can be incorporated in the determination of similar drugs are also suggested.
细菌对抗生素的耐药性是世界范围内一个日益严重的问题。考虑到抗菌药物对人群的相关性以及监管机构对新抗菌药物注册的减少,需要进行适当的质量控制,以最大限度地减少细菌耐药性的传播,并确保治疗的有效性和患者的安全性。最近加入抗菌药物领域的是恶唑烷酮类抗生素,它们特别有助于治疗革兰氏阳性菌引起的感染。依普硝唑和利奈唑胺(LIN)是恶唑烷酮类抗生素的两个成员。LIN 是第一个获得美国食品和药物管理局批准的恶唑烷酮类抗生素。本综述重点介绍了用于评估药品和生物基质中 LIN 的分析方法。讨论了单个方法的关键验证参数,如线性、检测限和定量限。还讨论了生物分析方法的关键质量属性,如灵敏度和样品制备技术。此外,还提出了一些可以应用于类似药物测定的未来趋势。