A Validated 2D-LC-UV Method for Simultaneous Determination of Imatinib and N-desmethylimatinib in Plasma and its Clinical Application for Therapeutic Drug Monitoring with GIST Patients / Houli Li, Di Zhang, Xiaoliang Cheng, Qiaowei Zheng, Kai Cheng, Lilong Xiong, Maoyi Wang, Weihua Dong, Weiyi Feng
Background: The trough concentration (C min ) of Imatinib (IM) is closely related to the treatment outcomes and adverse reactions of patients with gastrointestinal stromal tumors (GIST). However, the drug plasma level has great inter- and intra-individual variability, and therapeutic drug monitoring (TDM) is highly recommended. Objective: To develop a novel, simple, and economical two-dimensional liquid chromatography method with the ultraviolet detector (2D-LC-UV) for simultaneous determination of IM and its major active metabolite, N-desmethyl imatinib (NDIM) in human plasma, and then apply the method for TDM of the drug. Methods: The sample was processed by simple protein precipitation. Two target analytes were separated on the one-dimension column, captured on the middle column, and then transferred to the two-dimension column for further analysis. The detection was performed at 264 nm. The column temperature was maintained at 40˚C and the injection volume was 500 μL. Totally 32 plasma samples were obtained from patients with GIST who were receiving IM. Results: IM and NDIM were separated well from other impurities and the entire analytical time for each run was 12.0 min. The calibration curves had good linearity in the range of 33.5-2678.4 ng/mL for IM, and 20.0-1600.0 ng/mL for NDIM, respectively. The extraction efficiency was more than 95%. The acceptable accuracy, precision, recovery and stability were also obtained. The C min of the drug in patients was measured with the validated method. Conclusion: The novel 2D-LC-UV method is simple, stable, highly automated and independent of specialized technicians, which greatly increases the real-time capability of routine TDM for IM in hospital.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:18 |
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| Enthalten in: |
Current pharmaceutical analysis - 18(2022), 1, Seite 10 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Li, Houli [VerfasserIn] |
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| Links: |
FID Access [lizenzpflichtig] |
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| Umfang: |
1 Online-Ressource (10 p) |
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| Förderinstitution / Projekttitel: |
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KFL011170042 |
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| 245 | 1 | 2 | |a A Validated 2D-LC-UV Method for Simultaneous Determination of Imatinib and N-desmethylimatinib in Plasma and its Clinical Application for Therapeutic Drug Monitoring with GIST Patients |c Houli Li, Di Zhang, Xiaoliang Cheng, Qiaowei Zheng, Kai Cheng, Lilong Xiong, Maoyi Wang, Weihua Dong, Weiyi Feng |
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| 520 | |a Background: The trough concentration (C min ) of Imatinib (IM) is closely related to the treatment outcomes and adverse reactions of patients with gastrointestinal stromal tumors (GIST). However, the drug plasma level has great inter- and intra-individual variability, and therapeutic drug monitoring (TDM) is highly recommended. Objective: To develop a novel, simple, and economical two-dimensional liquid chromatography method with the ultraviolet detector (2D-LC-UV) for simultaneous determination of IM and its major active metabolite, N-desmethyl imatinib (NDIM) in human plasma, and then apply the method for TDM of the drug. Methods: The sample was processed by simple protein precipitation. Two target analytes were separated on the one-dimension column, captured on the middle column, and then transferred to the two-dimension column for further analysis. The detection was performed at 264 nm. The column temperature was maintained at 40˚C and the injection volume was 500 μL. Totally 32 plasma samples were obtained from patients with GIST who were receiving IM. Results: IM and NDIM were separated well from other impurities and the entire analytical time for each run was 12.0 min. The calibration curves had good linearity in the range of 33.5-2678.4 ng/mL for IM, and 20.0-1600.0 ng/mL for NDIM, respectively. The extraction efficiency was more than 95%. The acceptable accuracy, precision, recovery and stability were also obtained. The C min of the drug in patients was measured with the validated method. Conclusion: The novel 2D-LC-UV method is simple, stable, highly automated and independent of specialized technicians, which greatly increases the real-time capability of routine TDM for IM in hospital | ||
| 700 | 1 | |a Zhang, Di |e verfasserin |4 aut | |
| 700 | 1 | |a Cheng, Xiaoliang |e verfasserin |4 aut | |
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| 700 | 1 | |a Cheng, Kai |e verfasserin |4 aut | |
| 700 | 1 | |a Xiong, Lilong |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Maoyi |e verfasserin |4 aut | |
| 700 | 1 | |a Dong, Weihua |e verfasserin |4 aut | |
| 700 | 1 | |a Feng, Weiyi |e verfasserin |4 aut | |
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