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

ABSTRACT

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(8515,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.