Development of a UPLC-MS/MS method for the determination of orelabrutinib in rat plasma and its application in pharmacokinetics
The aim of the present study was to establish an ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method for the determination of orelabrutinib in rat plasma using futibatinib as internal standard (IS), and to apply it for a pharmacokinetic study in rats. Orelabrutinib w...
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Frontiers Media S.A.
2022-09-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2022.991281/full |
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| author | Ya-nan Liu Ya-nan Liu Yingying Hu Jing Wang Jing Wang Chaojie Chen Jianping Cai Ren-ai Xu Zhongqiu Lu |
| author_facet | Ya-nan Liu Ya-nan Liu Yingying Hu Jing Wang Jing Wang Chaojie Chen Jianping Cai Ren-ai Xu Zhongqiu Lu |
| author_sort | Ya-nan Liu |
| collection | DOAJ |
| description | The aim of the present study was to establish an ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method for the determination of orelabrutinib in rat plasma using futibatinib as internal standard (IS), and to apply it for a pharmacokinetic study in rats. Orelabrutinib was extracted from plasma by protein precipitation and quantitatively analyzed by UPLC-MS/MS. An Acquity UPLC BEH C18 column was used for rapid separation by gradient elution using 0.1% formic acid and acetonitrile as mobile phases. The validation results of bioanalytical methodology showed that the linearity of orelabrutinib in plasma samples was good within the concentration range of 1–2000 ng/ml. The lower limit of quantification (LLOQ) was 1 ng/ml. The precision of orelabrutinib ranged from 1.4% to 11.5%, with intra-day and inter-day accuracy ranging from −5.7% to 7.7% and −0.2% to 12.5%, respectively. The selectivity, stability, matrix effect and recovery of the method all met the requirements of quantitative analysis of biological samples. The method was simple, sensitive, accurate and specific, and had high recovery rate. It also could be successfully applied to the pharmacokinetic study of rats. |
| first_indexed | 2024-12-10T15:02:21Z |
| format | Article |
| id | doaj.art-cb5be97952fd44069489a57f808a3612 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-12-10T15:02:21Z |
| publishDate | 2022-09-01 |
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| series | Frontiers in Pharmacology |
| spelling | doaj.art-cb5be97952fd44069489a57f808a36122022-12-22T01:44:08ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-09-011310.3389/fphar.2022.991281991281Development of a UPLC-MS/MS method for the determination of orelabrutinib in rat plasma and its application in pharmacokineticsYa-nan Liu0Ya-nan Liu1Yingying Hu2Jing Wang3Jing Wang4Chaojie Chen5Jianping Cai6Ren-ai Xu7Zhongqiu Lu8Department of Pharmacy, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, ChinaInstitute of Molecular Toxicology and Pharmacology, School of Pharmaceutical Sciences, Wenzhou Medical University, Wenzhou, Zhejiang, ChinaDepartment of Pharmacy, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, ChinaDepartment of Pharmacy, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, ChinaInstitute of Molecular Toxicology and Pharmacology, School of Pharmaceutical Sciences, Wenzhou Medical University, Wenzhou, Zhejiang, ChinaEmergency Department, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, ChinaEmergency Department, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, ChinaDepartment of Pharmacy, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, ChinaEmergency Department, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, ChinaThe aim of the present study was to establish an ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method for the determination of orelabrutinib in rat plasma using futibatinib as internal standard (IS), and to apply it for a pharmacokinetic study in rats. Orelabrutinib was extracted from plasma by protein precipitation and quantitatively analyzed by UPLC-MS/MS. An Acquity UPLC BEH C18 column was used for rapid separation by gradient elution using 0.1% formic acid and acetonitrile as mobile phases. The validation results of bioanalytical methodology showed that the linearity of orelabrutinib in plasma samples was good within the concentration range of 1–2000 ng/ml. The lower limit of quantification (LLOQ) was 1 ng/ml. The precision of orelabrutinib ranged from 1.4% to 11.5%, with intra-day and inter-day accuracy ranging from −5.7% to 7.7% and −0.2% to 12.5%, respectively. The selectivity, stability, matrix effect and recovery of the method all met the requirements of quantitative analysis of biological samples. The method was simple, sensitive, accurate and specific, and had high recovery rate. It also could be successfully applied to the pharmacokinetic study of rats.https://www.frontiersin.org/articles/10.3389/fphar.2022.991281/fullpharmacokineticUPLC-MS/MSorelabrutinibprotein precipitationmethodological verificationrat |
| spellingShingle | Ya-nan Liu Ya-nan Liu Yingying Hu Jing Wang Jing Wang Chaojie Chen Jianping Cai Ren-ai Xu Zhongqiu Lu Development of a UPLC-MS/MS method for the determination of orelabrutinib in rat plasma and its application in pharmacokinetics Frontiers in Pharmacology pharmacokinetic UPLC-MS/MS orelabrutinib protein precipitation methodological verification rat |
| title | Development of a UPLC-MS/MS method for the determination of orelabrutinib in rat plasma and its application in pharmacokinetics |
| title_full | Development of a UPLC-MS/MS method for the determination of orelabrutinib in rat plasma and its application in pharmacokinetics |
| title_fullStr | Development of a UPLC-MS/MS method for the determination of orelabrutinib in rat plasma and its application in pharmacokinetics |
| title_full_unstemmed | Development of a UPLC-MS/MS method for the determination of orelabrutinib in rat plasma and its application in pharmacokinetics |
| title_short | Development of a UPLC-MS/MS method for the determination of orelabrutinib in rat plasma and its application in pharmacokinetics |
| title_sort | development of a uplc ms ms method for the determination of orelabrutinib in rat plasma and its application in pharmacokinetics |
| topic | pharmacokinetic UPLC-MS/MS orelabrutinib protein precipitation methodological verification rat |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2022.991281/full |
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