摘要
目的改进盐酸吉西他滨有关物质的测定方法。方法采用迪马C8(250mm×4.6mm,5μm)色谱柱,梯度洗脱检查,流速为1.0mL·min-1,检测波长275nm。结果在0.005～2.402μg/mL范围线性关系良好,相关系数r>0.999(n=5),重复性试验的RSD<0.0005%(n=6)。结论本方法简单、准确、重现性好,可用于盐酸吉西他滨的有关物质检查。
Objective To improve the determination of related substances in gemcitabine hydrochloride. Methods The determination was carried out on a Dikma C8（250 mm×4.6 mm,5μm）column with gradient elution.The detection wavelength of UV detector was 275 nm. Results There was a good linearity over the range of 0.005-2.402μg/mL with a the correlation coefficient higher than 0.999（n=5）.The RSD for repeatition was less than 0.0005%（n=6）. Conclusion The method was simple,accurate and good reproducibility,which can be used for the determination of related substances for gemcitabine hydrochloride.
出处
《中国医药科学》
2012年第18期106-108,共3页
China Medicine And Pharmacy
关键词
盐酸吉西他滨
有关物质
HPLC
Gemcitabine hydrochloride
Related substances
HPLC
