Journal
JOURNAL OF SEPARATION SCIENCE
Volume 36, Issue 5, Pages 840-848Publisher
WILEY-V C H VERLAG GMBH
DOI: 10.1002/jssc.201200919
Keywords
Clinical dosing; High sensitivity; Microdosing; Mirodenafil
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Funding
- Ministry of Health & Welfare, Republic of Korea [A070001]
- The Catholic University of Korea
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A high-sensitivity LC/MS/MS method was developed and validated for the simultaneous determination of mirodenafil and its major metabolite, SK-3541, in human plasma. Mirodenafil, SK-3541, and udenafil as an internal standard were extracted from plasma samples with methyl tert-butyl ether. Chromatographic separation was performed on a Luna phenyl-hexyl column (100 x 2.0 mm) with an isocratic mobile phase consisting of 5 mM ammonium formate and ACN (23:77, v/v) at a flow rate of 0.35 mL/min. Detection and quantification were performed using a mass spectrometer in selected reaction monitoring mode with positive ESI at m/z 532.3 296.1 for mirodenafil, m/z 488.1 296.1 for SK-3541, and m/z 517.3 283.2 for udenafil. The calibration curves were linear over a concentration range of 2-500 pg/mL using 0.5 mL plasma for the microdose of mirodenafil (100 g). Analytical method validation of the clinical dose (100 mg), with a calibration curve range of 2-500 ng/mL using 0.025-mL plasma, was also conducted. The other LC-MS/MS conditions were similar to those used for the microdosing. Each method was applied successfully to pharmacokinetic studies after a microdose or clinical dose of mirodenafil to six healthy Korean male volunteers.
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