A novel chiral HPLC method development and validation for sensitive detection of isomeric impurities in L-α-glycerylphosphorylcholine (L-α-GPC) from distinct sources: chemical synthesis versus bio-derivative
文献类型：期刊论文
| 作者 | Ji, Yuze2,3; Li, Xiaoyu2,3; Bian, Yifei1; Gao, Yangjing1; Xiang, Lili3; Sun, Ling3; Han, Haiyun3; Chen, Dongying1,2,3 |
| 刊名 | MICROCHEMICAL JOURNAL
 |
| 出版日期 | 2025-10-01 |
| 卷号 | 217页码:6 |
| 关键词 | L-alpha-glycerylphosphorylcholine (L-alpha-GPC) Isomeric impurity Chiral HPLC D-alpha-GPC /3-GPC Quality control |
| ISSN号 | 0026-265X |
| DOI | 10.1016/j.microc.2025.115036 |
| 英文摘要 | L-alpha-glycerylphosphorylcholine (L-alpha-GPC) structurally exhibits an enantiomer (D-alpha-GPC) and an achiral positional isomer (/3-GPC), both of which are regarded as isomeric impurities that require sensitive determination for safety considerations. In this study, a novel chiral HPLC method was developed to determine the isomeric impurities in L-alpha-GPC products sourced from chemical synthesis and bio-derivative, respectively. A satisfactory separation was achieved on a Chiralcel OX-H column (250 x 4.6 mm, 5 mu m) using a mobile phase composed of n-heptane, isopropanol and methanol (52:45:3, v/v/v) with 0.1 % formic acid and 0.2 % triethylamine as additives. A strategy for preparing L-alpha-GPC sample solutions at an optimally elevated concentration was specifically established to ensure excellent miscibility with the mobile phase and achieve a sensitive detection threshold of 0.025 % (w/w, relative to L-alpha-GPC) for both isomeric impurities. It was found that the developed chiral HPLC method could differentiate quality variations in terms of the content of isomeric impurities detected in commercial L alpha-GPC products, and these quality variations could be attributed to the differences in quality control methodology. Therefore, the developed chiral HPLC method is strongly recommended for strict quality control of commercial L-alpha-GPC products sourced either from bio-derivative or chemical synthesis. |
| WOS关键词 | ABSOLUTE-CONFIGURATION |
| WOS研究方向 | Chemistry |
| 语种 | 英语 |
| WOS记录号 | WOS:001595312600010 |
| 出版者 | ELSEVIER |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/320656]  |
| 专题 | 中国科学院上海药物研究所 |
| 通讯作者 | Chen, Dongying |
| 作者单位 | 1.Nanjing Univ Chinese Med, Sch Chinese Mat Med, 138 Xianlin Rd, Nanjing 210023, Peoples R China 2.Univ Chinese Acad Sci, 19A Yuquan Rd, Beijing 100049, Peoples R China 3.Chinese Acad Sci, Shanghai Inst Mat Med, Lab Pharmaceut Anal, 555 Rd Zuchongzhi,Zhangjiang Hitech Pk, Shanghai 201203, Peoples R China |
| 推荐引用方式 GB/T 7714 | Ji, Yuze,Li, Xiaoyu,Bian, Yifei,et al. A novel chiral HPLC method development and validation for sensitive detection of isomeric impurities in L-α-glycerylphosphorylcholine (L-α-GPC) from distinct sources: chemical synthesis versus bio-derivative[J]. MICROCHEMICAL JOURNAL,2025,217:6. |
| APA | Ji, Yuze.,Li, Xiaoyu.,Bian, Yifei.,Gao, Yangjing.,Xiang, Lili.,...&Chen, Dongying.(2025).A novel chiral HPLC method development and validation for sensitive detection of isomeric impurities in L-α-glycerylphosphorylcholine (L-α-GPC) from distinct sources: chemical synthesis versus bio-derivative.MICROCHEMICAL JOURNAL,217,6. |
| MLA | Ji, Yuze,et al."A novel chiral HPLC method development and validation for sensitive detection of isomeric impurities in L-α-glycerylphosphorylcholine (L-α-GPC) from distinct sources: chemical synthesis versus bio-derivative".MICROCHEMICAL JOURNAL 217(2025):6. |
入库方式： OAI收割
来源：上海药物研究所
浏览0
下载0
收藏0
其他版本
除非特别说明，本系统中所有内容都受版权保护，并保留所有权利。