Validated LC–MS/MS method for quantification of agomelatine in human plasma and its application in a pharmacokinetic study |
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| Authors: | Satish R Patil Ketan K Nerurkar Ashok M Kalamkar Vishwas Pukale Kiran V Mangaonkar Satish G Pingale |
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| Institution: | 1. Department of pharmacology, SVKMS NMIMS University, , Mumbai, 400056 India;2. Drug Monitoring Research Institute, , 400701 Navi Mumbai, India;3. Analytical Chemistry Research Laboratory, Mithibai College of Arts, Chauhan Institute of Science & Amrutben Jivanlal College of Commerce and Economics, , Mumbai, 400056 India |
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| Abstract: | An analytical method based on liquid–liquid extraction has been developed and validated for analysis of agomelatine in human plasma. Fluoxetine was used as an internal standard for agomelatine. A Betasil C18 (4.0 × 100 mm, 5 µm) column provided chromatographic separation of analytes followed by detection with mass spectrometry. The method involves simple isocratic chromatographic conditions and mass spectrometric detection in the positive ionization mode using an API‐4000 system. The proposed method has been validated with linear range of 0.050–8.000 ng/ml for agomelatine. The intra‐run and inter‐run precision values are within 12.12% and 9.01%, respectively, for agomelatine at the lower limit of quantification level. The overall recovery for agomelatine and fluoxetine was 67.10% and 72.96%, respectively. This validated method was used successfully for analysis of plasma samples from a pharmacokinetic study. Copyright © 2012 John Wiley & Sons, Ltd. |
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| Keywords: | liquid– liquid extraction tandem mass spectrometry agomelatine human plasma pharmacokinetic study |
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