Determination of tolperisone in human plasma by liquid chromatography/tandem mass spectrometry for clinical application

Chang Ik Choi, Jung In Park, Hye In Lee, Yun Jeong Lee, Choon Gon Jang, Jung Woo Bae, Seok Yong Lee

Research output: Contribution to journalArticlepeer-review

9 Scopus citations

Abstract

We have developed and validated a simple, rapid, and sensitive liquid chromatography analytical method employing tandem mass spectrometry (LC-MS/MS) for the determination of tolperisone, a centrally acting muscle relaxant, in human plasma. After liquid-liquid extraction with methyl t-butyl ether, chromatographic separation of tolperisone was performed using a reversed-phase Luna C18 column (2.0mm×50mm, 5μm particles) with a mobile phase of 10mM ammonium formate buffer (pH 3.5) - methanol (12:88, v/v) and quantified by tandem mass detection in ESI positive ion mode. The flow rate of the mobile phase was 250μL/min and the retention times of tolperisone and the internal standard (IS, dibucaine) were both 0.6min. The calibration curves were linear over a range of 0.5-300ng/mL (r>0.999). The lower limit of quantification, using 200μL human plasma, was 0.5ng/mL. The mean accuracy and precision for intra- and inter-day validation of tolperisone were within acceptable limits. The LC-MS/MS method reported here showed improved sensitivity for quantification of tolperisone in human plasma compared with previously described analytical methods. Lastly, the validated method was successfully applied to a pharmacokinetic study in humans.

Original languageEnglish
Pages (from-to)59-63
Number of pages5
JournalJournal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences
Volume911
DOIs
StatePublished - 1 Dec 2012

Keywords

  • Human plasma
  • LC-MS/MS
  • Pharmacokinetics
  • Tolperisone

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