Isolation, structural characterization and quantification of impurities in bupivacaine
文献类型：期刊论文
| 作者 | Cai, Pengjun1,2; Su, Yanhua1,2; Li, Yue1; Zhou, Hu1,2
|
| 刊名 | JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
 |
| 出版日期 | 2023-02-20 |
| 卷号 | 225页码:115236 |
| 关键词 | Bupivacaine N-oxide Isolation Characterization Single crystal Quantification |
| DOI | 10.1016/j.jpba.2023.115236 |
| 文献子类 | Article |
| 英文摘要 | Bupivacaine was found to be unstable during the accelerated storage condition(40 degrees C and 75% relative hu-midity), and two degradation impurities with the same protonated molecular ion were observed by high per-formance liquid chromatography-mass spectrometry (LC-MS). A semipreparative method was used to separate and purify the two impurities, and their structures were elucidated via comprehensive HR-MSMS and NMR spectroscopy analyses. Their stereo structures were characterized through single crystal X-ray diffraction. Meanwhile, an LC-MS method was developed and validated to quantify the two degradation impurities of bupivacaine. Chromatographic separation was performed on a C18 reversed-phase column (4.6 x 150 mm, 5 mu m) using an equivalent elution with water and methanol. The limits of quantitation for the two degradation im-purities (named RS1 and RS2) were 0.89 and 0.65 ng, respectively, and the average recoveries were in the range of 90 similar to 108% and relative standard deviations were less than 5.0%. The proposed LC-MS method can be used to control the quality of bupivacaine and its formulations. Data Availolity: Data will be made available on request. |
| WOS研究方向 | Chemistry ; Pharmacology & Pharmacy |
| 语种 | 英语 |
| WOS记录号 | WOS:000917338200001 |
| 出版者 | ELSEVIER |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/309722]  |
| 专题 | 新药研究国家重点实验室 |
| 通讯作者 | Li, Yue; Zhou, Hu |
| 作者单位 | 1.Chinese Acad Sci, Shanghai Inst Mat Media, Analyt Res Ctr Organ & Biol Mol, CAS Key Lab Receptor Res,State Key Lab Drug Res, 555 Zuchongzhi Rd, Shanghai 201203, Peoples R China; 2.Nanjing Univ Chinese Med, Sch Chinese Mat Med, 138 Xianlin Ave, Nanjing 210023, Jiangsu, Peoples R China; |
| 推荐引用方式 GB/T 7714 | Cai, Pengjun,Su, Yanhua,Li, Yue,et al. Isolation, structural characterization and quantification of impurities in bupivacaine[J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS,2023,225:115236. |
| APA | Cai, Pengjun,Su, Yanhua,Li, Yue,&Zhou, Hu.(2023).Isolation, structural characterization and quantification of impurities in bupivacaine.JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS,225,115236. |
| MLA | Cai, Pengjun,et al."Isolation, structural characterization and quantification of impurities in bupivacaine".JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS 225(2023):115236. |
入库方式： OAI收割
来源：上海药物研究所
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