Abstract
An LC–MS method for the determination of dothiepin in human plasma was developed and validated. Sample preparation involved extraction with n-hexane:2-propanol (95:5). Separation was on an Ultimate XB C18 column (2.1 × 150 mm, 5 μm). A single-quadrupole mass spectrometer with an electrospray interface was operated in the selected-ion monitoring mode to detect the [M+H]+ ions at m/z 296 for dothiepin and at m/z 278 for the internal standard (amitriptylene). The method demonstrated good linearity from 0.78 ng mL−1 (the LOQ) to100 ng mL−1. The mean extraction recovery was 82.4% for dothiepin and and 84.2% for the internal standard. The intra-day and inter-day precision ranged from 8.5 to 11.4% and 9.7 to 12.1% (RSD), respectively. The method was successfully applied to bioequivalence studies of dothiepin hydrochloride tablets to obtain the pharmacokinetic parameters.
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Chen, X., Chen, BM., Liu, SG. et al. Determination of Dothiepin in Human Plasma by LC–ESI–MS and its Application to Bioequivalence Studies. Chroma 68, 941–947 (2008). https://doi.org/10.1365/s10337-008-0835-8
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DOI: https://doi.org/10.1365/s10337-008-0835-8