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A validated UHPLC‐MS/MS method for determination of TQ‐B3203 in human plasma and its application to a pharmacokinetic study in Chinese patients with advanced solid tumor
Author(s) -
Yang Fen,
Zhou Jun,
Bo Yunhai,
Yin Han,
Liu Xiao Hong,
Li Jian
Publication year - 2021
Publication title -
journal of separation science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.72
H-Index - 102
eISSN - 1615-9314
pISSN - 1615-9306
DOI - 10.1002/jssc.202001023
Subject(s) - chromatography , chemistry , pharmacokinetics , formic acid , high performance liquid chromatography , acetonitrile , calibration curve , methanol , detection limit , pharmacology , medicine , organic chemistry
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‐d 8 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 C 8 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.