HPLC法测定紫连搽剂中左旋紫草素的含量及两种不同计算方法的不确定度评价  

Content Determination of L-shikonin in Zilian Liniment and Evaluation the Uncertainty of 2 Calculation Methods

作　　者：张红梅 姜潇 刘学起 

机构地区：[1]济南市食品药品检验检测中心,济南250102

出　　处：《中国药房》2015年第36期5149-5151,共3页China Pharmacy

摘　　要：目的：建立测定紫连搽剂中左旋紫草素含量的方法,并对测定结果的两种不同计算方法进行不确定度评价.方法：采用高效液相色谱法.色谱柱为Waters C18,流动相为甲醇-0.025 mol/L磷酸（85：15,V/V）,流速为1.0 ml/min,检测波长为516 nm,柱温为室温,进样量为10μl.对标准曲线法、外标一点法计算含量的过程和步骤进行量化分析,评价其不确定度.结果：左旋紫草素检测质量浓度线性范围为4.024～80.48μg/ml;精密度、稳定性、重复性试验的RSD〈2.0%;加样回收率为RSD为88.5%～93.1%, RSD为2.0%（n=6）.用标准曲线法测定含量,其扩展不确定度为0.70μg/ml;用外标一点法测定含量,其扩展不确定度为0.30μg/ml.结论：外标一点法测定紫连搽剂中左旋紫草素的含量更经济,更便捷,引入的不确定度更低.OBJECTIVE：To establish a method for the content determination of L-shikonin in Zilian liniment and evaluate the uncertainty by 2 calculation methods. METHODS：HPLC was performed on the column of Waters C18 with mobile phase of metha-nol-0.025 mol/L phosphate（85：15,V/V）at flow rate of 1.0 ml/min,the detection wavelength was 516 nm,column temperature was room temperature,and the injection volume was 10 μl. Quantitative analysis was conducted for the process and procedures calculat-ed by standard curve method and external standard method,and the uncertainty was evaluated. RESULTS：The linear range of L-shi-konin was 4.024-80.48μg/ml;RSDs of precision,stability and reproducibility test were lower than 2.0%;recovery was 88.5%-93.1%（RSD=2.0%,n=6）. Standard curve method was used to determine the content,and the expanded uncertainty was 0.70 μg/ml;ex-ternal standard method was used to determine the content,and the expanded uncertainty was 0.30 μg/ml. CONCLUSIONS：Stan-dard curve method is more economical,more convenient and lower uncertainty in the content determination of L-shikonin in Zilian liniment.

关 键 词：左旋紫草素 紫连搽剂 含量测定 不确定度 

分 类 号：R927.1[医药卫生—药学]