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

作者：Choi Chang Ik; Park Jung In; Lee Hye In; Lee Yun Jeong; Jang Choon Gon; Bae Jung Woo; Lee Seok Yong^*

来源：Journal of Chromatography B-Analytical Technologies in the Biomedical and Life Sciences, 2012, 911: 59-63.

DOI：10.1016/j.jchromb.2012.10.027

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

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 C-18 column (2.0 mm x 50 mm, 51 mu m particles) with a mobile phase of 10 mM 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 250 mu L/min and the retention times of tolperisone and the internal standard (IS, dibucaine) were both 0.6 min. The calibration curves were linear over a range of 0.5-300 ng/mL(r %26gt; 0.999). The lower limit of quantification, using 200 mu L human plasma, was 0.5 ng/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.

• 出版日期2012-12-12