HPLC替代对照品法同时测定莪术油及其注射液中6种成分的含量  

Simultaneous determination by HPLC of 6 components in zedoary turmeric oil and its related injections with replacement method of chemical reference substance

作　　者：何欢[1] 马双成[1] 张启明[1] 田颂九[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2009年第11期1892-1899,共8页Chinese Journal of Pharmaceutical Analysis

基　　金：国家十一五科技支撑计划;常见与重要药品安全标准研究(2006BAI14B01)

摘　　要：目的:建立HPLC替代对照品法同时测定莪术油及其注射液中6种成分含量。方法:本文采用HPLC方法,在不同条件下测定=牛儿酮与其他5种成分(莪术二酮、莪术醇、莪术烯、呋喃二烯及β-榄香烯)间的相对校正因子(RCF)。以上述6种成分为指标,分别利用替代对照品法和常规含量测定方法对莪术油及其注射液进行含量测定。色谱条件:采用Waters Symme-try C18(4.6 mm×250 mm,5μm)色谱柱,流动相为甲醇-水,梯度洗脱,流速1.0 mL.min-1,柱温30℃,检测波长215 nm。结果:以替代对照品法测得的结果与常规含量测定方法结果一致。结论:本试验在高效液相液相色谱仪上使用替代对照品法同时测定了莪术油及其注射液中的6种成分的含量,结果证明,本方法经济实用,可以高效、准确地对莪术油及其注射液进行质量控制。Objective： To establish and validate an HPLC method with single marker to simultaneously determine six components in zedoary turmeric oil and its related injections. Methods： The relative correction factors（RCF） of the five components（curdione, curcumol, curzerene, furanodiene, β-elemene） were measured by HPLC under different conditions with germacrone as standard reference. Assay of zedoary turmeric oil and its related injections was determined by replacement method of chemical reference substance and the conventional HPLC method with the above six components as the index components.The analysis was performed on a Waters Symmetry C18（46 mm×250 mm, 5 m） column; The mobile phase was composed of methanol-water with a linear gradient elution; The flow rate was 10 mL·min^-1 and the temperature of column was 30 ℃; The UV detection wavelength was set at 215 nm. Results：The quantitative results of the new method were almost consistent with the results of conventional HPLC method. Conclusion：For the first time, the replacement method of chemical reference substance is adopted in HPLC simultaneous determination of zedoary turmeric oil and its related injections. The new method is economical and practical which is highly effective and accurate for quality control of zedoary turmeric oil and its related injections.

关 键 词：HPLC 替代对照品法 莪术油 莪术油注射液 含量测定 

分 类 号：R917[医药卫生—药物分析学]