摘要
目的:建立高效液相色谱法测定注射用单磷酸阿糖腺苷有关物质含量的检测方法。方法:色谱柱为依利特Hypersil BDS C18(4.6 mm×250 mm,5μm),柱温为30℃,流动相为甲醇-磷酸盐缓冲液(V∶V=20∶80),流速为1 ml/min,进样量为10μl,检测波长为260 nm。结果:单磷酸阿糖腺苷杂质成分分离度高,已知杂质阿糖腺苷和腺嘌呤线性关系良好,相关系数分别为0.999 9和0.999 8,检出限分别为0.89 ng和1.04 ng。结论:该法用于测定注射用单磷酸阿糖腺苷有关物质的含量,操作简单、结果可靠,值得推广。
OBJECTIVE： To establish HPLC determination for the related substances in vidarabine monophosphate for injection. METHODS： The sample was separated on Yilite Hypersil BDS C18（ 4. 6 mm × 250 mm,5 μm） with methanol-phosphate buffer（ V ∶ V = 20 ∶ 80） as the mobile phase at flow rate of 1 ml / min,column temperature of 30 ℃and detection wavelength of 260 nm. RESULTS： The related substances in vidarabine monophosphate were wellseparated. The correlation coefficient of vidarabine was 0. 999 9 and that of adenine was 0. 999 8,with detection limit at 0. 89 ng for vidarabine and 1. 04 ng for adenine. CONCLUSIONS： The established determination method is simple in operation,reliable in results and thus it is worthy of clinical promotion.
出处
《中国医院用药评价与分析》
2015年第7期857-859,共3页
Evaluation and Analysis of Drug-use in Hospitals of China
