基于DRS origin的替代标准物质法研究——以超高效液相色谱测定乳香中11-羰基-β-乳香酸和11-羰基-β-乙酰乳香酸的含量为例  

Study on Substitute Reference Substance Method with DRS Origin Software: A Case Study of Determination of 11-keto-β-boswellic Acid and 11-keto-β-acetyl-boswellic Acid in Frankincense by UHPLC

作　　者：孙彩林 孙磊[1] 王赵[1] 金红宇[1] 马双成[1] 

机构地区：[1]中国食品药品检定研究院

出　　处：《中国药学杂志》2019年第17期1411-1417,共7页Chinese Pharmaceutical Journal

基　　金：国家自然科学基金项目资助(81303214,81373955);国家十二五“重大新药创制”专项资助(2014ZX09304307-002)

摘　　要：目的以建立乳香中11-羰基-β-乳香酸( KBA)和 11-羰基-β-乙酰乳香酸( AKBA)含量测定方法为例,探讨基于DRS origin 软件的替代标准物质法用于色谱峰定性和定量的可行性与准确性。方法使用超高效液相色谱建立含量测定方法,以AKBA为参照物,考察在19根不同C18色谱柱上使用DRS origin软件对KBA定性的准确性;考察检测波长微小变化对相对校正因子的影响,并对替代标准物质法与外标法定量结果进行比较。结果建立的方法符合方法学验证的要求,其平均回收率为100. 21%( n= 6 ), RSD = 2. 4 7 %。使用 DRS origin软件可准确定性色谱峰;该条件下测得KBA相对于AKBA的相对校正因子为0.936,且在不同条件下保持恒定;使用该相对校正因子计算所得含量与外标法所得结果无明显差异。结论本方法智能、简便、准确且成本较低,可用于乳香的含量测定。OBJECTIVE To establish a UHPLC method for determination of the contents of 11-keto-β-boswellic acid( KAB) and 11-keto-β-acetyl-boswellic acid( AKBA)in Frankincense and explore the suitability and accuracy of substitute reference substance meth od with DRS origin software for qualitative and quantitative determination of chromatographic peaks. METHODS The samples were separated by UHPLC for determination of AKBA and KBA. AKBA was used as a reference to investigate the accuracy of KBA identifi cation using DRS origin software on 19 different C18 columns. The RSDs of relative correction factors were calculated for different detec tion wavelengths and instruments. The relative correction factor method and the external standard method were selected for quantification and the differences were compared. RESULTS The established method met the requirements of methodology and the average recovery was 100.2 1 %(n = 6 )with RSD of 2. 47%. The DRS origin software can be used to accurately determine the chromatographic peaks. The correct factor of AKBA vs. KBA was 0. 936 and it was consistent under different conditions. There were no significant differences between the content calculated by the relative correction factor method and by the external standard method. CONCLUSION This method is intelligent, feasible, reliable and economical, and can be used for the determination of frankincense content.

关 键 词：乳香 11-羰基-Β-乙酰乳香酸 11-羰基-β-乳香酸 替代标准物质法 相对校正因子 超高效液相色谱法 DRS ORIGIN软件 

分 类 号：R917[医药卫生—药物分析学]