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Ultra-performance liquid chromatography-tandem mass spectrometric method for quantitation of the recently Food and Drug Administration approved combination of vaborbactam and meropenem in human plasma.
Royal Society Open Science ( IF 2.9 ) Pub Date : 2020-07-08 , DOI: 10.1098/rsos.200635
Ahmed K Kammoun 1 , Alaa Khedr 1 , Ahdab N Khayyat 1 , Maha A Hegazy 2
Affiliation  

A parenteral medical combination containing vaborbactam and meropenem is used mainly to treat complicated urinary tract infections. A novel ultra-performance liquid chromatography tandem mass spectrometric method was developed for the sensitive determination of both compounds in human plasma. Sample preparation was performed by precipitation technique. The chromatographic separation was accomplished using the Acquity C18-BEH column, 0.01 M ammonium formate: acetonitrile (47 : 53, v/v) as a mobile phase with a flow rate of 0.2 ml min−1. Analytes were monitored by applying multiple reaction monitoring. The bioanalytical validation criteria were conducted following the Food and Drug Administration recommendations. The method was linear within range 0.5 to 50 µg ml−1, for both drugs. The intra-day and inter-day precision, as coefficient variation (% CV) and the accuracy, as % bias did not exceed 15% for both drugs. The percentage recovery of targeted analytes was not less than 77%, calculated at three quality control levels. The proposed method showed a suitable lower level of quantification value of 0.50 µg ml−1 for both analytes, which is far lower than the expected Cmax, which permits the use of this method for pharmacokinetic studies. The proposed method proved to be useful for the evaluation of this combination in both human plasma and pharmaceutical formulation.



中文翻译:


超高效液相色谱-串联质谱法用于定量美国食品和药物管理局最近批准的人血浆中的伐波巴坦和美罗培南组合。



含有伐波巴坦和美罗培南的肠外药物组合主要用于治疗复杂的尿路感染。开发了一种新型超高效液相色谱串联质谱方法,用于灵敏测定人血浆中的两种化合物。通过沉淀技术进行样品制备。使用Acquity C18-BEH柱,0.01M甲酸铵:乙腈(47:53,v/v)作为流动相,流速0.2ml min -1完成色谱分离。通过应用多重反应监测来监测分析物。生物分析验证标准是根据食品和药物管理局的建议进行的。对于两种药物,该方法在 0.5 至 50 µg ml -1范围内呈线性。两种药物的日内和日间精度(系数变异 (% CV))和准确度(% 偏倚)均不超过 15%。按三个质量控制水平计算,目标分析物的回收率不低于 77%。所提出的方法显示了两种分析物的合适的较低水平的定量值0.50 µg ml -1 ,这远低于预期的C max ,这允许使用该方法进行药代动力学研究。所提出的方法被证明可用于评估人血浆和药物制剂中的这种组合。

更新日期:2020-07-20
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