Wu Xiu-Jun, Huang Xin, Shi Hai-Yan, Chen Xing-Kai, Dong Qian, Hao Guo-Xiang, Li Yan, Zheng Yi, Zhao Wei
Laboratory of Clinical Pharmacokinetic of TCM, Affiliated Hospital of Liaoning University of Traditional Medicine, Shenyang, China.
Department of Pharmacy, Shandong Provincial Qianfoshan Hospital, Shandong University, Jinan, China.
Biomed Chromatogr. 2018 Apr;32(4). doi: 10.1002/bmc.4143. Epub 2017 Dec 20.
A rapid, accurate and specific high-performance liquid chromatography-tandem mass spectrometry method has been validated for the simultaneous determination of cefoperazone and sulbactam in a small volume sample for children. A Shim-pack XR-ODS C column with gradient elution of water (0.1% formic acid) and acetonitrile (0.1% formic acid) solution was used for separation at a flow rate of 0.3 mL/min. The calibration curves of two analytes in serum showed excellent linearity over the concentration ranges of 0.03-10 μg/mL for cefoperazone, and 0.01-3 μg/mL for sulbactam, respectively. This method involves simple sample preparation steps and was validated according to standard US Food and Drug Administration and European Medicines Agency guidelines in terms of selectivity, linearity, detection limits, matrix effects, accuracy, precision, recovery and stability. This assay can be easily implemented in clinical practice to determine concentrations of cefoperazone and sulbactam in children.
已验证一种快速、准确且特异的高效液相色谱-串联质谱法，用于同时测定儿童小体积样本中的头孢哌酮和舒巴坦。采用Shim-pack XR-ODS C柱，以水（0.1%甲酸）和乙腈（0.1%甲酸）溶液进行梯度洗脱，流速为0.3 mL/min进行分离。血清中两种分析物的校准曲线在头孢哌酮浓度范围为0.03 - 10 μg/mL、舒巴坦浓度范围为0.01 - 3 μg/mL时分别显示出良好的线性。该方法涉及简单的样品制备步骤，并根据美国食品药品监督管理局和欧洲药品管理局的标准指南，在选择性、线性、检测限、基质效应、准确性、精密度、回收率和稳定性方面进行了验证。该测定法可轻松应用于临床实践，以测定儿童体内头孢哌酮和舒巴坦的浓度。
