高效液相色谱法测定乙酰乌头碱片含量及含量均匀度

Determination of Content and Content Uniformity of Acetylaconitine in Acetylaconitine Tablets by HPLC

目的建立测定乙酰乌头碱片含量及含量均匀度的高效液相色谱法。方法色谱柱为Waters Bridge C18柱(250 mm×4.6 mm,5μm),流动相为0.1%碳酸氢铵溶液-乙腈(60∶40,V∶V),检测波长为232 nm,流速为1.0mL/min,进样量为20μL。结果乙酰乌头碱质量浓度在6.0~60.2μg/m L范围内与峰面积线性关系良好(r=0.999 8);平均回收率为96.91%,RSD为0.58%(n=9);3批样品的平均含量分别为100.21%,99.14%,99.72%,含量均匀度(A+2.2 S)分别为12.23,8.61,9.32。结论该方法简便准确,重复性好,专属性强,可用作乙酰乌头碱片的质量控制。

Objective To establish an HPLC method for the determination of content and content uniformity of acetylaconitine in Acetylaconitine Tablets.Methods The chromatographic column was Waters Bridge C18 column(250 mm×4.6 mm,5μm),the mobile phase was 0.1%ammonium bicarbonate solution-acetonitrile(60∶40,V∶V),the detection wavelength was 232 nm,the flow rate was1.0 m L/min and the sample size was 20μL.Results Acetylacidine showed good linear relationship with peak area in the range of6.0-60.2μg/m L(r=0.999 8),the average recovery was 96.91%and RSD was 0.58%(n=9).The average contents of three batches of samples were 100.21%,99.14%and 99.72%,the content uniformity(A+2.2 S)of three batches of samples was 12.23,8.61 and 9.32,respectively.Conclusion The method is simple,accurate,reproducible and specific,which is suitable for the quality control of Acetylaconitine Tablets.