A validated LC-MS/MS method for the quantitation of daratumumab in rat serum using rapid tryptic digestion without IgG purification and reduction
文献类型：期刊论文
| 作者 | Li, Weiqiang3,4; Huang, Wensi3,4; Yu, Xiong2,4; Chen, Chong1,4; Yuan, Yali1,4; Liu, Donghui1,4; Wang, Feiyu1,4; Yu, Jinghua4; Diao, Xingxing3,4 |
| 刊名 | JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
 |
| 出版日期 | 2024-06-15 |
| 卷号 | 243页码:8 |
| 关键词 | Daratumumab LC-MS/MS Surrogate peptide Pharmacokinetics |
| ISSN号 | 0731-7085 |
| DOI | 10.1016/j.jpba.2024.116083 |
| 通讯作者 | Yu, Jinghua(yujinghua2@simm.ac.cn) ; Diao, Xingxing(xxdiao@simm.ac.cn) |
| 英文摘要 | Daratumumab, a humanized monoclonal antibody utilized in treating immunoglobulin light-chain amyloidosis and relapsed/refractory multiple myeloma, was quantified in rat serum through a simple, economical and effective liquid chromatography tandem-mass spectrometry (LC-MS/MS) method. A surrogate peptide, LLIYDASNR, derived from trypsin hydrolysis, was quantitatively analyzed with LLIYDASN [13C6, 15N4] RAT as an internal standard. This corrected variations from sample pretreatment and mass spectrometry response, involving denaturation and trypsin hydrolysis in a two-step process lasting approximately 1 hour. Methodological validation demonstrated a linear range of 1 mu g/mL to 1000 mu g/mL in rat serum. Precision, accuracy, matrix effect, sensitivity, stability, selectivity, carryover, and interference met acceptance criteria. The validated LC-MS/ MS approach was successfully applied to a pharmacokinetic study of daratumumab in rats at an intravenous dose of 15 mg/kg. |
| WOS关键词 | ANTIBODY-CONJUGATED DRUG ; QUANTIFICATION |
| 资助项目 | National Natural Science Foundation of China[82104276,82373938] |
| WOS研究方向 | Chemistry ; Pharmacology & Pharmacy |
| 语种 | 英语 |
| WOS记录号 | WOS:001204538700001 |
| 出版者 | ELSEVIER |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/310656]  |
| 专题 | 中国科学院上海药物研究所 |
| 通讯作者 | Yu, Jinghua; Diao, Xingxing |
| 作者单位 | 1.Nanjing Univ Chinese Med, Sch Chinese Mat Med, Nanjing 210023, Peoples R China 2.Ocean Univ China, Sch Med & Pharm, Qingdao 266003, Peoples R China 3.Univ Chinese Acad Sci, Beijing 100049, Peoples R China 4.Chinese Acad Sci, Shanghai Inst Mat Med, Shanghai 201210, Peoples R China |
| 推荐引用方式 GB/T 7714 | Li, Weiqiang,Huang, Wensi,Yu, Xiong,et al. A validated LC-MS/MS method for the quantitation of daratumumab in rat serum using rapid tryptic digestion without IgG purification and reduction[J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS,2024,243:8. |
| APA | Li, Weiqiang.,Huang, Wensi.,Yu, Xiong.,Chen, Chong.,Yuan, Yali.,...&Diao, Xingxing.(2024).A validated LC-MS/MS method for the quantitation of daratumumab in rat serum using rapid tryptic digestion without IgG purification and reduction.JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS,243,8. |
| MLA | Li, Weiqiang,et al."A validated LC-MS/MS method for the quantitation of daratumumab in rat serum using rapid tryptic digestion without IgG purification and reduction".JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS 243(2024):8. |
入库方式： OAI收割
来源：上海药物研究所
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