文档介绍：HPLC 测定硫唑嘌呤片有关物质

1,2 1 2
匡荣,陈男,倪维芳( 310014;,杭州 310004)

摘要:目的采用高效液相色谱法测定硫唑嘌呤片有关物质。方法采用十八烷基硅烷键合硅胶色谱柱(200 mm× mm,
5 μm),以甲醇-%醋酸钠溶液(18∶82)为流动相,流速为 mL·min1,检测波长为 300 nm。结果硫唑嘌呤片中的 2
个典型杂质 6-巯基嘌呤和 5-***-1-***-4-硝基咪唑的线性范围均为 ~ μg·mL1(r 分别为 7 和 9),检出
限分别为 ng 和 ng,平均回收率为 %(RSD=%)和 %(RSD=%)。结论高效液相色谱法测定
硫唑嘌呤片有关物质简便、快速,测定结果准确、可靠。
关键词:硫唑嘌呤片;有关物质;高效液相色谱法
中图分类号: 文献标志码:B 文章编号:1007-7693(2013)01-0180-04

HPLC Determination of the Related Substances in Azathioprine Tablets

KUANG Rong1,2, CHEN Nan1, NI Weifang2( of Pharmaceutical Science, Zhejiang University of Technology,
Hangzhou 310014, China; Institute for Food and Drug Control, Hangzhou 310004, China)

ABSTRACT: OBJECTIVE To establish an HPLC method for determination of related substances in Azathioprine Tablets.
METHODS The C18 column (200 mm× mm, 5 μm) was used. The mobile phase consisted of methanol and % of
sodium acetate solution(18∶82) at the flow rate of mL·min1, and the detection wavelength was set at 300 nm. RESULTS
The linear ranges of the two typical related substances mercaptopuring and 5-chloro-1-methyl-4-nitroimidazole in Azathioprine
Tablets were all  μg·mL1(r= and ) with the detection limits of ng and ng, and the average
recove