摘要
文章应用高效液相色谱技术,建立盐酸苄丝肼中基因杂质肼残留的检测方法。色谱条件:色谱柱为0.25 m×4.6 mm×5μm的十八烷基硅烷键合硅胶柱;流动相:0.3 g/L乙二胺四乙酸二钠(EDTA-2Na)∶乙腈=30∶70;流速:1.0 mL/min;检测波长:305 nm;盐酸苄丝肼的基因杂质肼的线性相关系数(r)为0.995,检测限为0.000525μg/m L,定量限为0.00175μg/mL;回收率在95.6%~101.8%,精密度、中间精密度和溶液稳定性的重现性良好。该方法可检测盐酸苄丝肼中基因杂质的残留。
A HPLC method to determine genotoxic impurity hydrazine residues in Benserazide Hydrochloride is established and developed.Chromatography condition:column:0.25 m×4.6 mm×5µm octadecylsilane-bonded silica gel;mobile phase:0.3 g/EDTA-2Na:acetonitrile=30:70;flow rate:1.0 mL/min;detection wavelength:305 nm.For genotoxic impurity hydrazine in Benserazide Hydrochloride,the linear correlation coefficient(r)was 0.995,the limit of detection was 0.000525µg/mL,the limit of quantitation was 0.00175µg/mL,and recovery was within 95.6%~101.8%.The evaluation for precision,intermediate precision and stability of solution showed good repeatability.This method is suitable to determine the residual genotoxic impurities in Benserazide Hydrochloride.
作者
朱来赟
张丽波
郑轶芳
ZHU Laiyun;ZHANG Libo;ZHENG Yifang(Zhejiang Nexchem Pharmaceutical Co.,Ltd.,Jinhua 321000,China)
出处
《工业微生物》
2025年第6期222-224,共3页
Industrial Microbiology
