Rapid quantification of levosulpiride in human plasma using RP‐HPLC‐MS/MS for pharmacokinetic and bioequivalence study |
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| Authors: | Jin‐Hee Park Yoo‐Sin Park Si‐Youn Rhim Hyun‐Jin Kim Ok‐Hwa Jhee Yun‐Sik Lee Min‐Ho Lee Leslie M Shaw Ju‐Seop Kang |
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| Institution: | 1. Department of Pharmacology and Institute of Biomedical Sciences, College of Medicine;2. Department of Bioengineering, Hanyang University, Seoul 133‐791, South Korea;3. Department of Surgery, College of Medicine, Hanyang University, Seoul 133‐791, South Korea;4. Department of Practical Arts Education, Gongju National University of Education, Gongju, South Korea;5. Department of Medical Zoology, College of Medicine, Kyunghee University, Seoul 130‐701, South Korea;6. Department of Internal Medicine, College of Medicine, Hanyang University, Seoul, South Korea;7. Department of Pathology and Lab Medicine, College of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA |
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| Abstract: | A rapid and validated method for analysis of levosulpiride in human plasma using liquid chromatography coupled to tandem mass spectrometry was developed. Levosulpiride and tiapride (IS, internal standard) were extracted from alkalized plasma samples with ethylacetate and separation by RP‐HPLC. Detection was performed by positive ion electrospray ionization in multiple‐reaction monitoring mode, monitoring the transitions m/z 342.1 → m/z 112.2 and m/z 329.1 → m/z 213.2, for quantification of levosulpiride and IS, respectively. The standard calibration curves showed good linearity within the range of 2–200 ng/mL (r2 ≥ 0.9990). The lower limit of quantitation was 2 ng/mL. The retention times of levosulpiride (0.63 min) and IS (0.66 min) presented a significant time saving benefit of the proposed method. No significant metabolic compounds were found to interfere with the analysis. This method offered good precision and accuracy and was successfully applied for the pharmacokinetic and bioequivalence study of a 25 mg of levosulpiride tablet in 24 healthy Korean volunteers. Copyright © 2009 John Wiley & Sons, Ltd. |
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| Keywords: | levosulpiride LC‐MS/MS pharmacokinetics bioequivalence study |
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