摘要
目的采用离子色谱．抑制电导检测法测定环磷酰胺相关物质A的含量。方法采用色谱柱lonPac CS12A（250mm×4．0mm Analytical），以0．16％甲烷磺酸为流动相，流速为1．0mL·min^-1，检测器为电导检测器，柱温为25℃，进样量为25μL。结果环磷酰胺相关物质A的定量下限为1．8μg·mL^-1，检测限为0．54μg·mL^-1；在1．8～24μg·mL^-1内线性关系良好（r〉0．999），在不同浓度水平范围内的平均回收率为97．45％～99．81％，RSD〈3％。结论本方法选择性好，灵敏度高，结果可靠，可满足环磷酰胺相关物质A检验分析的需要。
OBJECTIVE To establish ion exchange chromatography-suppressed conductivity detection for the determination of related substance A in cyclophosphamide. METHODS Using a Ionpac CS12A column （250 mm×4.0 mm Analytical）, the mobile phase was 0.16% methane sulfonic acid, the flow rate was 1.0 mL·min^-1 with suppressed conductivity detector; the column temperature was 25 ℃; and the inject volume was 25 μL. RESULTS The detection and quantification limit was 0.54 and 1.8μg·mL^-1, respectively. The linear range for the content of degradation impurity A was 1.8-24 μg·mL^-1 （r〉0.999）, the average recoveries were in the range of 97.45%-99.81% with the relative standard deviation below 3%. CONCLUSION The method is simple, rapid, accurate and is suitable for the determination of cyclophosphamide degradation impurity A.
出处
《中国现代应用药学》
CAS
CSCD
2014年第5期567-570,共4页
Chinese Journal of Modern Applied Pharmacy
关键词
离子色谱法
抑制电导检测法
环磷酰胺
相关物质A
ion chromatography
suppressed conductivity detection
cyclophosphamide
related substance A
