Simultaneous determination of tolterodine and its two metabolites, 5-hydroxymethyltolterodine and N-dealkyltolterodine in human plasma using LC-MS/MS and its application to a pharmacokinetic study
- Authors
- Kim, YH[Kim, Young-Hoon]; Byeon, JY[Byeon, Ji-Yeong]; Kim, SH[Kim, Se-Hyung]; Lee, CM[Lee, Choong-Min]; Jung, EH[Jung, Eui Hyun]; Chae, WK[Chae, Won Ki]; Jang, CG[Jang, Choon-Gon]; Lee, SY[Lee, Seok-Yong]; Lee, YJ[Lee, Yun Jeong]
- Issue Date
- Nov-2017
- Publisher
- PHARMACEUTICAL SOC KOREA
- Keywords
- Tolterodine; Hydroxymethyltolterodine; N-dealkyltolterodine; LC-MS/MS; Human plasma
- Citation
- ARCHIVES OF PHARMACAL RESEARCH, v.40, no.11, pp.1287 - 1295
- Indexed
- SCIE
SCOPUS
KCI
- Journal Title
- ARCHIVES OF PHARMACAL RESEARCH
- Volume
- 40
- Number
- 11
- Start Page
- 1287
- End Page
- 1295
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/26674
- DOI
- 10.1007/s12272-017-0981-3
- ISSN
- 0253-6269
- Abstract
- Tolterodine is a nonselective muscarinic antagonist that is indicated for the overactive urinary bladder and other urinary difficulties. We developed and validated a simple, rapid and sensitive high-performance liquid chromatography analytical method utilizing tandem mass spectrometry (LC-MS/MS) for the quantitation of tolterodine and its major metabolites, 5-hydroxymethyltolterodine (5-HMT) and N-dealkyltolterodine (NDT), in human plasma. After liquid-liquid extraction with methyl t-butyl ether, chromatographic separation of the three analytes was achieved using a reversed-phase Luna Phenyl-hexyl column (100 x 2.0 mm, 3 mu m particles) with a mobile phase of 10 mM ammonium formate buffer (pH 3.5)-methanol (10:90, v/v) and quantified by MS/MS detection in electrospray ionization (ESI) positive ion mode. The retention time of tolterodine, 5-HMT, NDT, and internal standard (IS) were 1.4, 1.24, 1.33, and 1.26 min, respectively. The calibration curves were linear over a range of 0.025-10 ng/ml for tolterodine and 5-HMT, and 0.05-10 ng/ml for NDT. The lower limit of quantifications using 200 mu l of human plasma was 0.025 ng/ml for tolterodine and 5-HMT, and 0.05 ng/ml for NDT. The mean accuracy and precision for intra- and inter-run validation of tolterodine, 5-HMT, and NDT were all within acceptable limits. These results showed that a simple, rapid and sensitive LC-MS/MS method for the quantification of tolterodine and its major metabolites in human plasma was developed. This method was successfully applied to a pharmacokinetic study in humans.
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