Simple and sensitive LC‐MS/MS‐based assay for the quantification of dimemorfan in human plasma for use in a pharmacokinetic study |
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| Authors: | Hongyi Tan Jinfu Peng Qi Pei Liu Yang Jun Chen Chengxian Guo Ye Hua Hong Yuan Guoping Yang |
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| Affiliation: | 1. Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China;2. School of Pharmaceutical Sciences, Central South University, Changsha, Hunan, China |
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| Abstract: | Dimemorfan phosphate has been widely used for 40 years throughout the world for the treatment of coughs. This is the first report on the use of an LC‐MS/MS‐based assay for the determination of dimemorfan in human plasma using estazolam as an internal standard after one‐step protein precipitation with acetonitrile. Chromatographic separation was achieved on a Phenomenex Luna C18 column (3 µm, 50 × 2.0 mm) using a fast gradient method, which involves water and methanol as the mobile phase (both containing 0.1% formic acid). Dimemorfan and estazolam were detected with proton adducts at m/z values of 255.8 → 155.1 and 295.0 → 267.0, respectively, in the selected reaction monitoring positive mode. The linear dynamic range of the assay was 0.04–5.00 ng/mL. The chromatographic run time for each plasma sample was <5 min. The method was proven to be accurate, precise, and repeatable. Finally, the developed method was successfully applied for the determination of dimemorfan in a pharmacokinetic study using healthy Chinese subjects. Copyright © 2014 John Wiley & Sons, Ltd. |
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| Keywords: | dimemorfan LC‐MS/MS method validation human plasma pharmacokinetics |
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