Qualification and Application of a Liquid Chromatography-Quadrupole Time-of-Flight Mass Spectrometric Method for the Determination of Adalimumab in Rat Plasma
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 signatur...
Main Authors: | , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
MDPI AG
2018-05-01
|
Series: | Pharmaceutics |
Subjects: | |
Online Access: | http://www.mdpi.com/1999-4923/10/2/61 |
id |
doaj-9c3a2375532c491bb117266b59ff98d9 |
---|---|
record_format |
Article |
spelling |
doaj-9c3a2375532c491bb117266b59ff98d92020-11-25T01:05:58ZengMDPI AGPharmaceutics1999-49232018-05-011026110.3390/pharmaceutics10020061pharmaceutics10020061Qualification and Application of a Liquid Chromatography-Quadrupole Time-of-Flight Mass Spectrometric Method for the Determination of Adalimumab in Rat PlasmaYuri Park0Nahye Kim1Jangmi Choi2Min-Ho Park3Byeong ill Lee4Seok-Ho Shin5Jin-Ju Byeon6Young G. Shin7College of Pharmacy and Institute of Drug Research and Development, Chungnam National University, Daejeon 34134, KoreaCollege of Pharmacy and Institute of Drug Research and Development, Chungnam National University, Daejeon 34134, KoreaCollege of Pharmacy and Institute of Drug Research and Development, Chungnam National University, Daejeon 34134, KoreaCollege of Pharmacy and Institute of Drug Research and Development, Chungnam National University, Daejeon 34134, KoreaCollege of Pharmacy and Institute of Drug Research and Development, Chungnam National University, Daejeon 34134, KoreaCollege of Pharmacy and Institute of Drug Research and Development, Chungnam National University, Daejeon 34134, KoreaCollege of Pharmacy and Institute of Drug Research and Development, Chungnam National University, Daejeon 34134, KoreaCollege of Pharmacy and Institute of Drug Research and Development, Chungnam National University, Daejeon 34134, KoreaA 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.http://www.mdpi.com/1999-4923/10/2/61adalimumabimmunoprecipitationliquid chromatography-quadrupole TOF MSbioanalysis |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Yuri Park Nahye Kim Jangmi Choi Min-Ho Park Byeong ill Lee Seok-Ho Shin Jin-Ju Byeon Young G. Shin |
spellingShingle |
Yuri Park Nahye Kim Jangmi Choi Min-Ho Park Byeong ill Lee Seok-Ho Shin Jin-Ju Byeon Young G. Shin Qualification and Application of a Liquid Chromatography-Quadrupole Time-of-Flight Mass Spectrometric Method for the Determination of Adalimumab in Rat Plasma Pharmaceutics adalimumab immunoprecipitation liquid chromatography-quadrupole TOF MS bioanalysis |
author_facet |
Yuri Park Nahye Kim Jangmi Choi Min-Ho Park Byeong ill Lee Seok-Ho Shin Jin-Ju Byeon Young G. Shin |
author_sort |
Yuri Park |
title |
Qualification and Application of a Liquid Chromatography-Quadrupole Time-of-Flight Mass Spectrometric Method for the Determination of Adalimumab in Rat Plasma |
title_short |
Qualification and Application of a Liquid Chromatography-Quadrupole Time-of-Flight Mass Spectrometric Method for the Determination of Adalimumab in Rat Plasma |
title_full |
Qualification and Application of a Liquid Chromatography-Quadrupole Time-of-Flight Mass Spectrometric Method for the Determination of Adalimumab in Rat Plasma |
title_fullStr |
Qualification and Application of a Liquid Chromatography-Quadrupole Time-of-Flight Mass Spectrometric Method for the Determination of Adalimumab in Rat Plasma |
title_full_unstemmed |
Qualification and Application of a Liquid Chromatography-Quadrupole Time-of-Flight Mass Spectrometric Method for the Determination of Adalimumab in Rat Plasma |
title_sort |
qualification and application of a liquid chromatography-quadrupole time-of-flight mass spectrometric method for the determination of adalimumab in rat plasma |
publisher |
MDPI AG |
series |
Pharmaceutics |
issn |
1999-4923 |
publishDate |
2018-05-01 |
description |
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. |
topic |
adalimumab immunoprecipitation liquid chromatography-quadrupole TOF MS bioanalysis |
url |
http://www.mdpi.com/1999-4923/10/2/61 |
work_keys_str_mv |
AT yuripark qualificationandapplicationofaliquidchromatographyquadrupoletimeofflightmassspectrometricmethodforthedeterminationofadalimumabinratplasma AT nahyekim qualificationandapplicationofaliquidchromatographyquadrupoletimeofflightmassspectrometricmethodforthedeterminationofadalimumabinratplasma AT jangmichoi qualificationandapplicationofaliquidchromatographyquadrupoletimeofflightmassspectrometricmethodforthedeterminationofadalimumabinratplasma AT minhopark qualificationandapplicationofaliquidchromatographyquadrupoletimeofflightmassspectrometricmethodforthedeterminationofadalimumabinratplasma AT byeongilllee qualificationandapplicationofaliquidchromatographyquadrupoletimeofflightmassspectrometricmethodforthedeterminationofadalimumabinratplasma AT seokhoshin qualificationandapplicationofaliquidchromatographyquadrupoletimeofflightmassspectrometricmethodforthedeterminationofadalimumabinratplasma AT jinjubyeon qualificationandapplicationofaliquidchromatographyquadrupoletimeofflightmassspectrometricmethodforthedeterminationofadalimumabinratplasma AT younggshin qualificationandapplicationofaliquidchromatographyquadrupoletimeofflightmassspectrometricmethodforthedeterminationofadalimumabinratplasma |
_version_ |
1725192132275208192 |