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Pharmaceutics 2018, 10(2), 61; https://doi.org/10.3390/pharmaceutics10020061

Qualification and Application of a Liquid Chromatography-Quadrupole Time-of-Flight Mass Spectrometric Method for the Determination of Adalimumab in Rat Plasma

College of Pharmacy and Institute of Drug Research and Development, Chungnam National University, Daejeon 34134, Korea
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Received: 16 April 2018 / Revised: 20 May 2018 / Accepted: 21 May 2018 / Published: 24 May 2018
(This article belongs to the Special Issue Drug Metabolism, Pharmacokinetics and Bioanalysis)
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Abstract

A liquid chromatography–quadrupole time-of-flight (Q-TOF) mass spectrometric method was developed for early-stage research on adalimumab in rats. The method consisted of immunoprecipitation followed by tryptic digestion for sample preparation and LC-QTOF-MS/MS analysis of specific signature peptides of adalimumab in the positive ion mode using electrospray ionization. This specific signature peptide is derived from the complementarity-determining region (CDR) of adalimumab. A quadratic regression (weighted 1/concentration), with an equation y = ax2 + bx + c, was used to fit calibration curves over the concentration range of 1–100 μg/mL for adalimumab. The qualification run met the acceptance criteria of ±25% accuracy and precision values for quality control (QC) samples. This qualified LC-QTOF-MS/MS method was successfully applied to a pharmacokinetic study of adalimumab in rats as a case study. This LC-QTOF-MS/MS approach would be useful as a complementary method for adalimumab or its biosimilars at an early stage of research. View Full-Text
Keywords: adalimumab; immunoprecipitation; liquid chromatography-quadrupole TOF MS; bioanalysis adalimumab; immunoprecipitation; liquid chromatography-quadrupole TOF MS; bioanalysis
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).
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Park, Y.; Kim, N.; Choi, J.; Park, M.-H.; Lee, B.; Shin, S.-H.; Byeon, J.-J.; Shin, Y.G. Qualification and Application of a Liquid Chromatography-Quadrupole Time-of-Flight Mass Spectrometric Method for the Determination of Adalimumab in Rat Plasma. Pharmaceutics 2018, 10, 61.

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