A validated UHPLC-MS/MS method for determination of TQ-B3203 in human plasma and its application to a pharmacokinetic
Fen Yang1, Jun Zhou2, Yunhai Bo1
1Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), National drug clinical trial center, Peking University Cancer Hospital & Institute, Beijing, P. R. China.
Abstract:
TQ-B3203 is a new topoisomerase I inhibitor derived from camptothecin. In this paper, a simple and reliable ultra high-performance liquid chromatography-tandem mass spectrometric method was developed and validated for determination of TQ-B3203 in human plasma with TQ-B3203-d8 used as the internal standard. Bis(p-nitrophenyl)phosphate (2 mol/L) was added to ensure the stability of TQ-B3203 in human plasma. Plasma samples were protein precipitated by methanol and processed samples were chromatographed on an AQUITY BEH C8 column (50 × 2.1 mm, id 1.7 μm) with acetonitrile and water (0.1% formic acid) as the mobile phase. The calibration curves showed good linearity (R≥0.99) over the concentration range of 0.5-500 ng/mL. Within- and between-run precision were ≤5.8% and the accuracy was within the range of -8.3 to 14.0%. This method was further successfully applied to a pharmacokinetic study of TQ-B3203 in Chinese advanced solid cancer patients after administration of TQ-B3203 liposome injection.
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