HPLC同时测定消炎利胆片中5种活性成分的含量

Simultaneous Determination of Five Active Components in Xiaoyanlidan Tablets by HPLC

关键词:  消炎利胆片  高效液相色谱法  含量测定  质量控制

Key words:  Xiaoyanlidan tablets  HPLC  content determination  quality control

摘要:

目的 建立HPLC同时测定消炎利胆片中5种活性成分（绿原酸、迷迭香酸、穿心莲内酯、芹菜素、脱水穿心莲内酯）的方法。方法 采用phenomonex^®-C₁₈色谱柱（4.6 mm×250 mm，5 μm），以乙腈（A）-0.4%的磷酸水溶液（B）为流动相进行梯度洗脱，流速为1.0 mL·min^-1，柱温为30℃，检测波长为330 nm（绿原酸、迷迭香酸、芹菜素）和254 nm（穿心莲内酯、脱水穿心莲内酯）。结果 绿原酸、迷迭香酸、穿心莲内酯、芹菜素和脱水穿心莲内酯检测浓度分别在3.042~121.7 μg·mL^-1、2.558~102.3 μg·mL^-1、14.11~564.4 μg·mL^-1、2.835~113.4 μg·mL^-1、23.86~954.3 μg·mL^-1内与峰面积呈良好的线性关系（r ≥ 0.999 6），平均加样回收率为97.90%~101.75%，RSD为0.89%~1.66%，仪器精密度、重复性、稳定性良好。结论 本试验所建立的方法准确可靠、重复性好，可为消炎利胆片的质量控制提供科学的依据。

Abstract:

OBJECTIVE To establish a method for simultaneous of chlorogenic acid, rosmarinic acid, andrographolide, apigenin and dehyandrographolide in Xiaoyanlidan tablets by HPLC. METHODS The HPLC separation was achieved on a phenomonex^®-C₁₈ (4.6 mm×250 mm, 5 μm) column. The mobile phase consisted of acetonitrile (A) and 0.4%phosphoric acid (B) solution with gradient elution. The flow rate was 1.0 mL·min^-1. The column temperature was 30℃. The detection wavelength was set at 330 nm(chlorogenic acid, rosmarinic acid and apigenin) and 254 nm (andrographolide, dehyandrographolide). RESULTS The linear range of chlorogenic acid, rosmarinic acid, andrographolide, apigenin and dehyandrographolide were 3.042-121.7 μg·mL^-1, 2.558-102.3 μg·mL^-1, 14.11-564.4 μg·mL^-1, 2.835-113.4 μg·mL^-1, 23.86-954.3 μg·mL^-1 respectively (r ≥ 0.999 6); the average recoveries were 97.90%-101.75% and the corresponding RSD was 0.89%-1.66% respectively. The precision, repeatability and stability were good. CONCLUSION The established method is accurate, reliable and repeatable, which can provide a more comprehensive basis for quality control of Xiaoyanlidan tablets.