Highly sensitive method for the determination of ropinirole with a lower limit of quantitation of 3.45 pg/mL in human plasma by LC‐ESI‐MS/MS: application to a clinical pharmacokinetic study |
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| Authors: | D Vijaya Bharathi B Jagadeesh S Sirish Kumar Revathi Naga Lakshmi Kishore Kumar Hotha A Naidu Ramesh Mullangi |
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| Institution: | 1. Bioanalytical Department, Integrated Product Development, Dr Reddy's Laboratories Ltd, Bachupalli, Hyderabad‐500 072, India;2. Department of Chemistry, JNTU College of Engineering, Kukatpally, Hyderabad‐500 072, India;3. Biopharmaceutics Department, Integrated Product Development, Dr Reddy's Laboratories Ltd, Bachupalli, Hyderabad‐500 072, India;4. Current affiliation: Jubilant Innovation, 96 Industrial Suburb, 2nd Stage, Yeshwanthpur, Bangalore‐560022, India |
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| Abstract: | A highly sensitive, rapid assay method has been developed and validated for the estimation of ropinirole (RPR) in human plasma with liquid chromatography coupled to tandem mass spectrometry with electrospray ionization in the positive‐ion mode. A solid‐phase process was used to extract RPR and citalopram (internal standard, IS) from human plasma. Chromatographic separation was operated with 0.2% ammonia solution:acetonitrile (20:80, v/v) at a flow rate of 0.50 mL/min on a Hypurity C18 column with a total run time of 3.2 min. The MS/MS ion transitions monitored were 261.2 → 114.2 for RPR and 325.1 → 209.0 for IS. Method validation and clinical sample analysis were performed as per FDA guidelines and the results met the acceptance criteria. The lower limit of quantitation achieved was 3.45 pg/mL and the linearity was observed from 3.45 to 1200 pg/mL. The intra‐day and inter‐day precisions were in the range of 4.71–7.98 and 6.56–8.31%, respectively. This novel method has been applied to a pharmacokinetic study of RPR in humans. Copyright © 2008 John Wiley & Sons, Ltd. |
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| Keywords: | ropinirole LC‐MS/MS method validation human plasma pharmacokinetics |
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