A sensitive and rapid ultra-performance liquid chromatography coupled with -tandem mass spectrometry (UPLC-MS/MS) method was developed and validated to determine ceftibuten (CTB) and sulbactam (SUL) in human plasma. An ACQUITY UPLC HSS T3 C18 (2.1 × 100 mm), 1.8 μm column with gradient elution of water (0.1% formic acid) and acetonitrile was used for separation at a flow rate of 0.2 mL/min. This method involves a simple sample preparation with acetonitrile. The calibration curves of CTB and SUL in plasma showed good linearity over the concentration range of 0.50–25 μg/mL and with a correlation coefficient (r2) >0.99. This method was validated in terms of selectivity, linearity, precision, accuracy and stability. High precision was obtained with coefficients of variation <15%. Excellent recovery in the range of 90–104% was achieved for CTB and SUL was 86–110%. The method has the potential utility to support pharmacometric modeling in clinical practice and biopharmaceutic studies.

中文翻译：

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人血浆中头孢布烯和舒巴坦的 UPLC 串联质谱分析的开发和验证

开发并验证了一种灵敏快速的超高效液相色谱结合串联质谱 (UPLC-MS/MS) 方法来测定人血浆中的头孢布烯 (CTB) 和舒巴坦 (SUL)。采用 ACQUITY UPLC HSS T3 C18 (2.1 × 100 mm)、1.8 μm 色谱柱，用水（0.1% 甲酸）和乙腈梯度洗脱，以 0.2 mL/min 的流速进行分离。该方法涉及用乙腈进行简单的样品制备。血浆中CTB和SUL的校准曲线在0.50-25μg/mL的浓度范围内表现出良好的线性，相关系数(r2)>0.99。该方法在选择性、线性、精密度、准确度和稳定性方面得到了验证。获得了高精度，变异系数＜15％。 CTB 的回收率达到了 90-104%，SUL 的回收率为 86-110%。该方法具有支持临床实践和生物制药研究中药效学建模的潜在用途。