摘要
目的比较中国卫生部及美国药典(USP35)颁布的氨磷汀及其相关物质的高效液相(HPLC)测定方法。方法美国药典USP35测定方法采用C8色谱柱,流动相采用7∶18(甲醇∶0.94g/L己烷磺酸)溶液,检测波长为220nm,流速1.0m L/min;中国卫生部的标准采用C18色谱柱,流动相采用1∶1(甲醇∶3.5mmol/L辛烷磺酸钠)溶液,检测波长均为220nm,流速0.7 m L/min。结果两种方法检测氨磷汀及相关物质都符合对杂质的要求。结论美国药典USP35的检测方法对氨磷汀及相关物质检测的质量控制更好。
Objective To compare the HPLC measurement method for analysis amifostine,which validated by China Ministry of Public Health and United States Pharmacopeia（ USP 35）. Methods The HPLC methods for determination of amifostine,validated by USP 35 and China Ministry of Public Health Department were comparatively described. Amifostine and its related substances were determined with the mobile phase of 7∶ 18（ methanol∶ 0. 94 g /L hexanesulfonic acid sodium solution）,with flow rate of 1. 0m L/min and 1∶ 1（ methanol∶3. 5mmol / L octanesulfonic acid sodium solution,with flow rate of 0. 7m L / min,respectively. Wave length of the two standards’ detection was 220 nm. Results Both of the two standards were meet analysis requirement of amifostine and its related substances. Conclusion USP35 is better for the quality control of amifostine.
出处
《标记免疫分析与临床》
CAS
2015年第2期142-144,共3页
Labeled Immunoassays and Clinical Medicine
