UPLC-MS/MS Method for quantitation of the recently FDA approved combination of vaborbactam and meropenem in human plasma

A parenteral medical combination containing vaborbactam (VBR) and meropenem (MRP) is used mainly to treat complicated urinary tract infections. A novel ultra-performance liquid chromatography (UPLC)- tandem mass spectrometric (MS/MS) 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. Analytes were monitored by applying multiple reaction monitoring (MRM). The bioanalytical validation criteria were conducted following the FDA recommendations. The method was linear within range 0.5 to 50 µg/mL, for both drugs. The intra-day and inter-day precision, as coefficient variation (%CV) and the accuracy, as % bias not exceed than 15% for both drugs. The percentage recovery of targeted analytes was not less than 77 %, cal...