A robust and validated LC-MS/MS method for the quantification of ramucirumab in rat and human serum using direct enzymatic digestion without immunoassay
文献类型：期刊论文
| 作者 | Huang, Wen-si4,5; Li, Wei-qiang4,5; Yu, Xiong3,5; Xue, Ming-zhen2,5; Yuan, Ya-li1,5; Chen, Chong1,5; Wu, Ya-li4,5; Yu, Jing-hua5; Diao, Xing-xing4,5 |
| 刊名 | JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES
 |
| 出版日期 | 2024-02-15 |
| 卷号 | 1234页码:11 |
| ISSN号 | 1570-0232 |
| 关键词 | Anti -gastric cancer monoclonal antibody Ramucirumab LC -MS/MS Method validation Surrogate peptide |
| DOI | 10.1016/j.jchromb.2023.123991 |
| 通讯作者 | Yu, Jing-hua(yujinghua2@simm.ac.cn) ; Diao, Xing-xing(xxdiao@simm.ac.cn) |
| 英文摘要 | A new liquid chromatography tandem mass spectrometry (LC-MS/MS) method was established to quantify the anti -gastric cancer fully human monoclonal antibody (ramucirumab) in rat and human serum. The surrogate peptide (GPSVLPLAPSSK) for ramucirumab was generated by trypsin hydrolysis and quantified using the isotopically labeled peptide GPSVLPLAPSSK[13C6, 15N2]ST containing two more amino acids at the carboxyl end as an internal standard to correct for variations introduced during the enzymatic hydrolysis process and any mass spectrometry changes. Additionally, the oxidation and deamidation of unstable peptides (VVSVLTVLHQDWLNGK and NSLYLQMNSLR) were detected. The quantitative range of the proposed method was 1-1000 mu g/mL, and complete methodological validation was performed. The precision, accuracy, matrix effect, sensitivity, stability, selectivity, carryover, and interference of the measurements met the required standards. The validated LC-MS/MS method was applied to pharmacokinetic studies in rats administered ramucirumab at 15 mg/kg intravenously. Overall, a robust, efficient, and cost-effective LC-MS/MS method was successfully developed for quantifying ramucirumab in rat and human serum. |
| WOS关键词 | MONOCLONAL-ANTIBODY ; NANO-SURFACE ; BIOLOGICAL MATRICES ; MASS-SPECTROMETRY ; PLASMA ; NIVOLUMAB ; QUANTITATION ; DEAMIDATION ; ASSAY |
| 资助项目 | National Natural Science Foundation of China[82104276] |
| WOS研究方向 | Biochemistry & Molecular Biology ; Chemistry |
| 语种 | 英语 |
| 出版者 | ELSEVIER |
| WOS记录号 | WOS:001170923400001 |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/309883]  |
| 专题 | 中国科学院上海药物研究所 |
| 通讯作者 | Yu, Jing-hua; Diao, Xing-xing |
| 作者单位 | 1.Nanjing Univ Chinese Med, Sch Chinese Mat Med, Nanjing 210023, Peoples R China 2.Nanjing Univ Chinese Med, Jiangsu Key Lab Funct Subst Chinese Med, Nanjing 210023, Peoples R China 3.Ocean Univ China, Sch Med & Pharm, Qingdao 266003, Peoples R China 4.Univ Chinese Acad Sci, Beijing 100049, Peoples R China 5.Chinese Acad Sci, Shanghai Inst Mat Med, Shanghai 201210, Peoples R China |
| 推荐引用方式 GB/T 7714 | Huang, Wen-si,Li, Wei-qiang,Yu, Xiong,et al. A robust and validated LC-MS/MS method for the quantification of ramucirumab in rat and human serum using direct enzymatic digestion without immunoassay[J]. JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES,2024,1234:11. |
| APA | Huang, Wen-si.,Li, Wei-qiang.,Yu, Xiong.,Xue, Ming-zhen.,Yuan, Ya-li.,...&Diao, Xing-xing.(2024).A robust and validated LC-MS/MS method for the quantification of ramucirumab in rat and human serum using direct enzymatic digestion without immunoassay.JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES,1234,11. |
| MLA | Huang, Wen-si,et al."A robust and validated LC-MS/MS method for the quantification of ramucirumab in rat and human serum using direct enzymatic digestion without immunoassay".JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES 1234(2024):11. |
入库方式： OAI收割
来源：上海药物研究所
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