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An improved UPLC method for rapid analysis of levofloxacin in human plasma

机译：一种改进的UPLC方法可快速分析人血浆中的左氧氟沙星

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A rapid, specific, and sensitive ultra-performance liquid chromatographic method for analysis of levofloxacin in human plasma has been developed and validated. Plasma samples were spiked with the internal standard (enoxacin) and extracted with 10:1 (v/v) ethyl acetate-isopropanol. UPLC was performed on a 100 x 2.1 mm i.d., 1.7 mu m particle, C-18 column with 88: 12 (v/v) 0.4% triethylamine buffer (pH 3)-acetonitrile as mobile phase, pumped isocratically at a pressure of 11,000 psi (758 bar) and a flow-rate of 0.3 mL min(-1). Ultraviolet detection was performed at 300 nm. The retention times of levofloxacin and enoxacin were 3.4 and 2.8 min, respectively, and the run-time was 5 min. Calibration showed that response was a linear function of concentration over the range 0.05-10 mu g mL(-1) (r(2) >= 0.99) and the method was validated over this range for both precision and accuracy. The relative standard deviation was < 15% for both intra-day and inter-day assay (n = 5). Levofloxacin and enoxacin were stable in plasma; there was no evidence of degradation during three freeze-thaw cycles, post-preparative stability at 20 degrees C was >= 24 h, short-term stability at room temperature was >= 6 h, and long-term stability at -70 degrees C was 30 days. The method was successfully used in a study of the bioequivalence of two levofloxacin tablet formulations in healthy volunteers.
机译：已经开发并验证了一种快速，特异性和灵敏的超高效液相色谱方法，用于分析人血浆中的左氧氟沙星。用内标（依诺沙星）加标血浆样品，并用10：1（v / v）乙酸乙酯-异丙醇萃取。 UPLC是在100 x 2.1 mm内径，1.7μm颗粒，C-18色谱柱上进行的，色谱柱使用88:12（v / v）0.4％三乙胺缓冲液（pH 3）-乙腈作为流动相，在11,000的压力下等度泵送psi（758 bar）和0.3 mL min（-1）的流速。紫外线检测是在300 nm处进行的。左氧氟沙星和依诺沙星的保留时间分别为3.4和2.8分钟，运行时间为5分钟。校准显示响应是浓度在0.05-10μg mL（-1）（r（2）> = 0.99）范围内的线性函数，并且该方法在此范围内的准确性和准确性均得到验证。日内和日间分析的相对标准偏差均<15％（n = 5）。左氧氟沙星和依诺沙星在血浆中稳定;在三个冻融循环中没有降解的迹象，在20摄氏度时的制备后稳定性> = 24小时，在室温下短期稳定性> = 6小时，在-70摄氏度下长期稳定性是30天。该方法已成功用于健康志愿者中两种左氧氟沙星片剂的生物等效性研究。

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