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A simple, rapid and sensitive liquid chromatography–tandem mass spectrometry (LC–MS/MS) method for the quantification of a newly developed antihypertensive agent fimasartan (BR-A657, Kanarb ® ) in human plasma was developed and validated. Fimasartan and internal standard (IS, BR-A563) were extracted by simple protein precipitation using acetonitrile and separated on a Phenyl-Hexyl column (Luna ® , 5 µm, 50 mm × 2.0 mm, Phenomenex) under the gradient conditions of mobile phase A (distilled water with 0.1% formic acid) and mobile phase B (100% acetonitrile with 0.1% formic acid) at a flow rate of 0.25 mL/min. Detection and quantification were performed by the mass spectrometer using multiple reaction monitoring mode at  m/z  500.2 → 221.2 for fimasartan and  m/z  524.3 → 204.9 for the IS. The assay was linear over a calibration range of 0.5–500 ng/mL with a lower limit of quantification of 0.5 ng/mL. The coefficient of variation of this assay precision was &lt;14.9% and the accuracy exceeded 91.9%. This method provided the necessary sensitivity, linearity, precision, accuracy and specificity to allow the determination of fimasartan after oral administration to healthy Korean male volunteers in several drug–drug interaction studies conducted at the Clinical Trials Center of Seoul National University Hospital.

Validated LC–MS/MS Assay for the Quantitative Determination of Fimasartan in Human Plasma: Application to Pharmacokinetic Studies