甘肃医药2026，Vol.45Issue(7)：611-615,5.DOI:10.15975/j.cnki.1004-2725.2026.07.009
甲硝唑片遗传毒性杂质研究
The study on genotoxic impurities of metronidazole tablets
摘要
Abstract
Objective:To assess the genotoxic impurities in metronidazole tablets.Methods:To evaluate the organic and inorganic impurities in metronidazole tablets according to ICH M7 guidelines.The seven impurities of metronidazole tablets specified in the European Pharmacopoeia(Ph.Eur.)were assessed and classified by(Q)SAR prediction.Meanwhile,the related substance method was validated and ver-ified,and an ion chromatography method was established for the determination of nitrite.Results:The impurity G was classified as class2,and the limit of the Ph.Eur.method should be tightened.The ion chromatography method for nitrite exhibited excellent sensitivity and speci-ficity.The linear range was16.60-82.98ng/mL(r=0.9997),and the recovery rate was 88.9-92.0%.Conclusions:It is suggested that the im-purity G should be limited to 0.005%,while the limit for nitrite should be 0.005%.The established method was suitable for the two impurities control.关键词
(定量)构效评价/甲硝唑片/基因毒性杂质/亚硝酸盐Key words
(Q)SAR assessment/metronidazole tablets/genotoxic impurities/nitrite分类
医药卫生引用本文复制引用
董双涛,李宝霞,董斌,刘尧,马郑..甲硝唑片遗传毒性杂质研究[J].甘肃医药,2026,45(7):611-615,5.基金项目
山西省中华职业教育社等2024年度医药食品大健康课题(编号:2024LH003) （编号:2024LH003）
