28批次扁咽口服液中肉桂酸的含量测定

Determination of cinnamic acid in 28 batches of Bianyan oral solution by HPLC

目的建立测定扁咽口服液中肉桂酸含量的高效液相色谱法,考察扁咽口服液的内在质量。方法色谱柱为Agilent Zorbax Eclipse XDB-C18(4.6 mm×150 mm,5μm),流动相为甲醇-1%冰醋酸溶液(50∶50),流速为1.0 mL/min,检测波长为285 nm,柱温为30℃。结果肉桂酸在0.005 1～0.202 9μg范围内与峰面积呈良好的线性关系(r=0.999 9)。平均加样回收率为99.94%,RSD为1.16%(n=6)。结论本方法测定扁咽口服液中肉桂酸的含量,操作简便,结果准确。同时提示应建立有效的质量控制标准,以保证临床用药安全、有效。

Objective To establish the determination method for cinnamic acid content in bianyan oral liquid by HPLC, and study the intrinsic quality of the bianyan oral liquid. Methods The Agilent Zorbax Eclipse XDB-CI8 （ 4. 6 mm x 150 mm, 5 μm） was used as the column, and the mobile phase was methanol - 1% acetic acid （ 50： 50） with the flow rate of 1.0 mL/min, the detection wavelength was 285 nm, and the column temperature was 30℃. Results Cinnamic acid showed a good linear relationship within a range of 0. 005 1 - 0. 202 9 μg （ r = 0. 999 9 ）, the average recovery rate was 99.94% , RSD = 1.16% （ n = 6 ）. Conclusion The method for determining the content of cinnamic acid in bianyan oral liquid is simple and accurate. The effective quality control standards should be established to ensure the safe and effective clinical treatment.