High-sensitive LC-MS/MS method for the simultaneous determination of mirodenafil and its major metabolite, SK-3541, in human plasma: Application to microdose clinical trials of mirodenafil
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. Chromatogra...
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| Published in | Journal of separation science Vol. 36; no. 5; pp. 840 - 848 |
|---|---|
| Main Authors | , , , |
| Format | Journal Article |
| Language | English |
| Published |
Weinheim
Blackwell Publishing Ltd
01.03.2013
Wiley Wiley Subscription Services, Inc |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1615-9306 1615-9314 1615-9314 |
| DOI | 10.1002/jssc.201200919 |
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| Abstract | 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 × 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 μg). 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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| AbstractList | 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 × 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 [arrow right] 296.1 for mirodenafil, m/z 488.1 [arrow right] 296.1 for SK-3541, and m/z 517.3 [arrow right] 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 µg). 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. [PUBLICATION ABSTRACT] 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 L una phenyl‐hexyl column (100 × 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 μg). 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. 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 × 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 μg). 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. 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 × 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 μg). 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.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 × 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 μg). 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. 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 mu g). Analytical method validation of the clinical dose (100 mg), with a calibration curve range of 2-500 mu g/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. |
| Author | Cho, Doo-Yeoun Bae, Soo Kyung Bae, Soo Hyeon Shon, Ji-Hong |
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| Cites_doi | 10.1016/j.jchromb.2007.08.011 10.1002/rcm.1790 10.2133/dmpk.DMPK‐12‐RG‐044 10.1007/s12272-011-1102-3 10.1007/s11095-008-9555-x 10.1016/j.clinthera.2009.12.012 10.1111/j.1743-6109.2008.00945.x 10.1097/FPC.0b013e3283489ce2 10.1002/jps.21160 10.1111/j.1365-2125.2006.02575.x 10.1111/j.1365-2710.2009.01159.x 10.1517/17425255.1.1.23 10.1016/j.jpba.2007.06.021 10.1002/jssc.201100089 10.1292/jvms.70.1199 10.1016/j.addr.2011.02.004 10.1038/clpt.2011.108 10.2165/00126839-200809020-00002 10.1021/ac020361s 10.4155/bio.10.6 10.1080/00498250701708521 |
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| Copyright | 2013 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim 2014 INIST-CNRS 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim. 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim |
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| Keywords | Biological fluid Tandem mass spectrometry Chemical analysis 3',5'-Cyclic-GMP phosphodiesterase Isozyme Metabolite HPLC chromatography Clinical dosing Esterases Phosphoric diester hydrolases Electrospray Blood Microdosing Blood plasma High sensitivity Clinical trial Quantitative analysis Human Validation Healthy subject Enzyme Coupled method Oral administration Enzyme inhibitor Phosphodiesterase 5 inhibitor Sensitivity Mirodenafil Simultaneous measurement Hydrolases Pharmacokinetics |
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| Snippet | 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... A high‐sensitivity LC / MS / MS method was developed and validated for the simultaneous determination of mirodenafil and its major metabolite, SK ‐3541, in... 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... |
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| SubjectTerms | Adult Analysis Biological and medical sciences Calibration Chromatography Chromatography, High Pressure Liquid - methods Clinical dosing Clinical trials Drug Dosage Calculations Erectile Dysfunction - drug therapy Ethers General pharmacology High sensitivity Human Humans Male Mass spectrometers Mass spectrometry Mathematical analysis Medical sciences Metabolites Microdosing Mirodenafil Monitoring Pharmacology Pharmacology. Drug treatments Plasma Pyrimidines - blood Pyrimidinones - blood Pyrimidinones - metabolism Pyrimidinones - therapeutic use Sensitivity and Specificity Separation Sulfonamides - blood Sulfonamides - metabolism Sulfonamides - therapeutic use Tandem Mass Spectrometry - methods Young Adult |
| Title | High-sensitive LC-MS/MS method for the simultaneous determination of mirodenafil and its major metabolite, SK-3541, in human plasma: Application to microdose clinical trials of mirodenafil |
| URI | https://api.istex.fr/ark:/67375/WNG-X0QH7K39-8/fulltext.pdf https://onlinelibrary.wiley.com/doi/abs/10.1002%2Fjssc.201200919 https://www.ncbi.nlm.nih.gov/pubmed/23390072 https://www.proquest.com/docview/1439927031 https://www.proquest.com/docview/1317406557 https://www.proquest.com/docview/1372631417 |
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