Analytical Sciences

Fully Validated Ultra-performance Liquid Chromatography–Tandem Mass Spectrometry Method for the Determination of Fimasartan in Human Plasma

Ji Yeon HYUN, Hyun-Ju KIM, Mi-Ri GWON, Hae Won LEE, Sook Jin SEONG, and Young-Ran YOON

Department of Biomedical Science, BK 21 Plus KNU Bio-Medical Convergence Program for Creative Talent and Clinical Trial Center, Kyungpook National University Graduate School and Hospital, Daegu 700-842, Republic of Korea

Fimasartan is a novel angiotensin II receptor blocker with strong anti-hypertensive activity. In this study, a more rapid and sensitive ultra-performance liquid chromatography–tandem mass spectrometry (UPLC-MS/MS) method to determine fimasartan in human plasma was developed and fully validated. The quantification of analytes was conducted by MS/MS in a multiple reaction monitoring mode at m/z 502.2 → 207.1 for fimasartan and m/z 526.3 → 207.1 for the internal standard (IS, BR-A-563). The method showed a linear response from 3 to 1000 ng/mL (r > 0.9950). The intra- and inter-day accuracy values were 86.9 – 98.2 and 93.3 – 100.1%, respectively. The intra- and inter-day precision values were 2.0 – 3.1 and 0.8 – 8.0%, respectively. This UPLC-MS/MS method was validated for specificity, linearity, precision, accuracy, recovery, system suitability, and stability, and was found to be acceptable for bioanalytical applications. Finally, this fully validated method was successfully applied to a pharmacokinetic study of fimasartan in healthy volunteers following oral administration.

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