工业微生物2025，Vol.55Issue(2)：253-256,4.DOI:10.3969/j.issn.1001-6678.2025.02.069
GC-MS法测定拉莫三嗪中潜在基因毒性杂质硫酸二正丙酯的含量
Determination of Potential Genotoxic Impurity Dipropyl Sulfate in Lamotrigine by GC-MS
摘要
Abstract
The paper aimed at establishing a GC-MS method for detecting the content of potential genotoxic impurity dipropyl sulfate in lamotrigine.The DM-624 capillary column(30 m×320 μm×1.8 μm)was used for chromatographic analysis,temperature programmed was used for separation,with splitless injection,and the data was collected in a single ion monitoring(SIM)model.The quantitative ion of dipropyl sulfate was m/z 43,and its qualitative ions were m/z 73 and m/z 42.This method had good specificity and no interference of solvent and matrix to the determination of dipropyl sulfate.The linear relationship was good when the mass concentration of dipropyl sulfate was in the range of 25.0-400.0 μg·L-1.The limit of detection(LOD)was 0.38 mg·kg-1 and the limit of quantitation(LOQ)was 0.94 mg·kg-1.The precision,repeatability and stability tests met the detection requirements.The recoveries were 93.71%-114.04%,and SRSD was 7.37%.The method proposed in the paper was accurate,sensitive,specific,and can be used for the determination of the potential genotoxic impurity dipropyl sulfate in lamotrigine.关键词
拉莫三嗪/硫酸二正丙酯/基因毒性杂质/含量测定/气相色谱-质谱法Key words
lamotrigine/dipropyl sulfate/genotoxic impurity/content determination/GC-MS引用本文复制引用
马晓宁,石笑弋,刘轶,姜金生,陈开义,陈俊..GC-MS法测定拉莫三嗪中潜在基因毒性杂质硫酸二正丙酯的含量[J].工业微生物,2025,55(2):253-256,4.基金项目
2025年湖南省自然科学基金"基于生理药动学(PBPK)模型在仿制药一致性评价中应用的示范性研究"(编号:2025JJ80136). （PBPK）
