UPLC法同时测定盐酸阿糖胞苷原料药的含量和有关物质  

Simultaneous Determination of Cytarabine Hydrochloride and Related Substances by UPLC

作　　者：海丽萍[1] 杨东菁[2] 王志远[3] 王雪芹[4] 

机构地区：[1]河南省直属机关第一门诊部,郑州450003 [2]河南大学医学院,河南开封475001 [3]河南大学药学院,河南开封475001 [4]河南省食品药品检验所,郑州450003

出　　处：《中国药房》2014年第12期1137-1140,共4页China Pharmacy

摘　　要：目的：建立同时测定盐酸阿糖胞苷原料药的含量和有关物质的方法。方法：采用超高效液相色谱法。色谱柱为Inertsil ODS-3 C18流动相为磷酸盐缓冲液-甲醇（梯度洗脱），流速为0．8ml／min，检测波长为254nm，柱温为40℃，进样量为10μl。结果：尿嘧啶、尿苷、阿糖尿苷、盐酸阿糖胞苷检测质量浓度分别在0．1008～20．16、0．1～20．12、0．0956～19．12、0.1～20．004μg／ml范围内与各自峰面积积分值呈良好的线性关系（r=0．9999、0．9998、0．9999、0.9999）；精密度、稳定性、重复性试验的RSD≤0．79％；尿嘧啶、尿苷、阿糖尿苷平均加样回收率为103．8％、102．2％、99．7％，RSD分别为2．44％、2．69％、3．16％（n=9）。结论：该方法准确、灵敏度高、专属性强、重复性好．可用于盐酸阿糖胞苷原料药的质量控制。OBJECTIVE： To establish a method for simultaneous determination of cytarabine hydrochloride and related substance. METHODS： UPLC method was adopted. The determination was performed on Inertsil ODS-3 CIS column with mobile phase consisted of phosphate buffer-methanol （gradient elution） at the flow rate of 0.8 ml/min; the detection wavelength was set at 254 nm and the column temperature was 40℃. The sample size was 10μl. RESULTS： The liner ranges were 0.100 8-20.16 μg/ml for uracil （r=0.999 9）, 0.1-20.12 μg/ml for uridine （r=0.999 8）, 0.0956-19.12 ug/ml for 1-β-D-arabino furanosyl-uracil （r=0.999 9） and 0.1-20.004 μg/ml for cytarabine hydrochloride （r=0.999 9）, respectively. RSD of precision, stability and reproducibility tests were all lower than 0.79%; average recoveries of uracil, wridine and 1-β-D-arabino furanosyl-uracil were 103.8% （RSD=2.44%, n=9）, 102.2% （RSD=2.69%, n=9） and 99.7% （RSD=3.16%, n=9）. CONCLUSIONS： The method is accurate, sensitive, specific and reproducible, and can be used for the quality control of cytarabine hydrochloride.

关 键 词：盐酸阿糖胞苷 尿嘧啶 尿苷 阿糖尿苷 超高效液相色谱法 含量测定 

分 类 号：R917[医药卫生—药物分析学]