A novel and highly precise method were developed and rigorously validated for quantifying ivacaftor (IVA), tezacaftor (TEZ), and elexacaftor (ELX) in human plasma. This method leverages multiple reaction-monitoring mass spectrometry for its analytical approach. During the validation process, the method demonstrated its robustness across a wide concentration range: 0.151 to 40.382 ng/ml for ELX, 0.101 to 30.010 ng/ml for IVA, and 20.187 to 6,026.032 ng/ml for TEZ in human plasma. Importantly, this method exhibited exceptional accuracy and reproducibility even at lower concentrations. The mobile phase employed in this analysis consisted of methanol and 0.1% formic acid at a ratio of 85:15 (v/v), with a flow rate set at 1.0 ml/minute. Additionally, linear correlations were established within the human plasma for ELX (R2=0.9983), IVA (R2=0.9992), and TEZ (R2=0.9989). In conclusion, this newly developed method is dependable and precise for the accurate quantification of IVA, TEZ, and ELX, especially when dealing with lower concentrations in human plasma analysis.
Key words: Ivacaftor, Tezacaftor, Elexacaftor, Lumacaftor, LC-MS/MS, Validation.
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