Development and Validation of UPLC Tandem Mass Spectrometry Assay for Ceftibuten and Sulbactam in Human Plasma
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abstract
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%25 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%25. Excellent recovery in the range of 90-104%25 was achieved for CTB and SUL was 86-110%25. The method has the potential utility to support pharmacometric modeling in clinical practice and biopharmaceutic studies.
Cephalosporins; Chromatography, High Pressure Liquid; Drug Stability; Humans; Limit of Detection; Linear Models; Reproducibility of Results; Sensitivity and Specificity; Sulbactam; Tandem Mass Spectrometry; High performance liquid chromatography; Sulfur determination; cephalosporin derivative; sulbactam; Calibration curves; Gradient elution; Human plasmas; Liquid chromatography coupled with tandem mass spectrometries; Sample preparation; Simple ; Tandem mass spectrometry; Tandem-mass spectrometry; Ultra performance liquid chromatography; UPLC-MS/MS; blood; chemistry; drug stability; high performance liquid chromatography; human; limit of detection; procedures; reproducibility; sensitivity and specificity; statistical model; tandem mass spectrometry; Plasma (human)
