Qualification and Application of a Liquid Chromatography-Quadrupole Time-of-Flight Mass Spectrometric Method for the Determination of Adalimumab in Rat Plasma
Yuri Park,
Nahye Kim,
Jangmi Choi,
Min-Ho Park,
Byeong ill Lee,
Seok-Ho Shin,
Jin-Ju Byeon,
Young G. Shin
Affiliations
Yuri Park
College of Pharmacy and Institute of Drug Research and Development, Chungnam National University, Daejeon 34134, Korea
Nahye Kim
College of Pharmacy and Institute of Drug Research and Development, Chungnam National University, Daejeon 34134, Korea
Jangmi Choi
College of Pharmacy and Institute of Drug Research and Development, Chungnam National University, Daejeon 34134, Korea
Min-Ho Park
College of Pharmacy and Institute of Drug Research and Development, Chungnam National University, Daejeon 34134, Korea
Byeong ill Lee
College of Pharmacy and Institute of Drug Research and Development, Chungnam National University, Daejeon 34134, Korea
Seok-Ho Shin
College of Pharmacy and Institute of Drug Research and Development, Chungnam National University, Daejeon 34134, Korea
Jin-Ju Byeon
College of Pharmacy and Institute of Drug Research and Development, Chungnam National University, Daejeon 34134, Korea
Young G. Shin
College of Pharmacy and Institute of Drug Research and Development, Chungnam National University, Daejeon 34134, Korea
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.