高效液相色谱法测定螨变应原注射液中防腐剂苯酚含量  

Determination of preservative phenol in mite allergons preparation injection by HPLC

作　　者：张瑾[1] 王瑾[1] 杨英超[1] 张影[1] 薄淑英[1] 王国柱[1] 辛晓芳[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2014年第8期1486-1488,共3页Chinese Journal of Pharmaceutical Analysis

基　　金：国家高技术研究发展计划(863计划)(编号2012AA02A402)

摘　　要：目的：建立高效液相色谱法测定螨变应原注射液中苯酚含量。方法：采用Watershed Novo-Pak C18（4μm,3.9 mm×150 mm）色谱柱,流动相为甲醇-水（40∶60）,流速1.0 mL·min-1,检测波长为270 nm。结果：苯酚浓度在21.56~107.8μg·mL-1范围呈良好的线性,r=0.9999;平均回收率（n=9）为99.1%。结论：本文方法经方法学验证可用于螨变应原注射液苯酚含量的测定。Objective： To establish the HPLC method for determination of phenol in mite allergons preparation.Methods： The sample was analyzed on a Waters Novo- Pak C18column（ 4 μm,3. 9 mm × 150 mm） with the mobile phase of methanol- water（ 40∶ 60）; the flow rate was 1. 0 mL·min- 1,and the detection wavelength was 270 nm.Results： The linear range of the phenol concentration was 21. 56- 107. 8 μg·mL- 1,r =0.9999; and the average recovery（ n = 9） of phenol was 99. 1%. Conclusion： This HPLC method can be applied to effective determination of phenol in mite allergons preparation,and the method meets the requirements for methodological validation.

关 键 词：螨变应原注射液 脱敏治疗药物 苯酚 防腐剂测定 治疗用生物制品质量控制 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]