Peng G W, Stryd R P, Murata S, Igarashi M, Chiba K, Aoyama H, Aoyama M, Zenki T, Ozawa N
Drug Metabolism Research Laboratories, Pharmacia and Upjohn Co., Kalamazoo, MI 49007, USA.
J Pharm Biomed Anal. 1999 Jun;20(1-2):65-73. doi: 10.1016/s0731-7085(98)00310-0.
An HPLC-UV method was developed for assay of linezolid in dog, rat, mouse, and rabbit plasma. Linezolid and the internal standard were extracted on a solid phase cartridge (SPE) and separated on a reversed-phase column (C8, 4.6x150 mm, 5 microm) with 20% acetonitrile in water as mobile phase. The SPE quantitatively recovered linezolid and the internal standard from plasma samples. The chromatographic peak height ratio or peak area ratio based on UV absorbency at 251 nm was used for quantitative analysis. The assay procedures were simple and the assay was specific and had adequate precision and accuracy. Calibration standards with concentrations over the range of 0.01 20 microg/ml were validated for routine sample analysis to support the pharmacokinetic and toxicology studies with linezolid in dog, rat, mouse, and rabbit. Analysis of quality control samples showed the coefficients of variation were usually <10% and the measured and theoretical concentrations differed by <10% in most assays. Linezolid in the plasma samples was stable when stored at below -20 degrees C for at least 63 days, at room temperature (22-23 degrees C) for up to 24 h, and after three freeze-thaw cycles. This HPLC method has been successfully used in multiple laboratories to assay plasma samples from pharmacokinetic and toxicology studies with linezolid in the animal species.
建立了一种HPLC-UV方法用于测定犬、大鼠、小鼠和兔血浆中的利奈唑胺。利奈唑胺和内标物在固相萃取柱（SPE）上进行萃取，并在反相柱（C8，4.6×150 mm，5μm）上分离，以20%乙腈水溶液为流动相。SPE能从血浆样品中定量回收利奈唑胺和内标物。基于251 nm处紫外吸收的色谱峰高比或峰面积比用于定量分析。该分析方法操作简单，具有特异性，且精密度和准确度良好。浓度范围为0.01～20μg/ml的校准标准品经验证可用于常规样品分析，以支持利奈唑胺在犬、大鼠、小鼠和兔体内的药代动力学和毒理学研究。质量控制样品分析表明，大多数分析中变异系数通常<10%，实测浓度与理论浓度相差<10%。血浆样品中的利奈唑胺在-20℃以下储存至少63天、室温（22-23℃）下储存长达24小时以及经过三次冻融循环后均稳定。该HPLC方法已成功应用于多个实验室，用于分析利奈唑胺在动物体内药代动力学和毒理学研究的血浆样品。
