摘要
建立以高效液相色谱法测定奥沙利铂注射液中的奥沙利铂有关物质和含量的方法,以碳十八烷基硅烷键合硅胶为填充剂,规格250mm×4.6mm,粒径5μm,以水-甲醇(90∶10)为流动相,流动相用0.45μm的膜过滤,紫外检测波长为250nm。奥沙利铂在50～1600μg/ml的浓度范围内,峰面积与浓度呈线性关系,线性曲线方程为A=3650.9C+17.095(r=0.9999),最低检测限为1.2ng。加样平均回收率为99.4%(RSD=0.81%,n=9)。本方法简便、灵敏、准确,可用于奥沙利铂注射液中的有关物质和含量的控制。
To establish the determination method of related substances and content of oxaliplatin injection by high performance liquid chromatography（HPLC）. HPLC is performed to determine octadecylsilyl silica gel chromatography column,250 mm × 4.6 mm,diameter 5 μ m,The mobile phase is methanol-water（10：90）,mobile phase by 0.45 μm membrane filter,the detecting wavelength is 250 nm. The detected concentration of oxaliplatin is in the good linear range of 50～1 600 μg/ml （r=1.000 0）,the limit of detection is 1.2 ng,and the average recovery is 99.4%（RSD=0.81%,n=9）. The established method is simple,sensitive,accurate and available for the quality control of oxaliplatin.
出处
《东华理工大学学报（自然科学版）》
CAS
2010年第3期290-292,共3页
Journal of East China University of Technology(Natural Science)
关键词
高效液相色谱法
奥沙利铂
有关物质
含量测定
high performance liquid chromatography
oxaliplatin
related substances
content assay
