高效液相色谱法对复方健胃分散片中延胡索乙素的含量测定及分析

Determination and analysis of Tetrahydropalmatine content in Compound stomach dispersible tablets by high performance liquid chromatography

目的:采用高效液相色谱法(HPLC)对中成药复方健胃分散片中延胡索乙素含量进行测定及分析。方法:采用HPLC法,色谱柱为Agilent TC-C18,即250 mm×4.6 mm,5.0μm,流动相0.1%的乙腈和pH值为6.4的醋酸水溶液,采用三乙胺溶液调节PH为6.4梯度洗脱,检测波长282 nm,流速1.0 mL/min。以延胡索乙素含量为指标,采用均匀设计法。结果:中成药复方健胃分散片中延胡索乙素的回归方程Y=15.99078X-7.09624(r=0.9997),延胡索乙素在0.1～1.0μg/mL范围内与峰面积呈现良好的线性关系;平均加样回收率为99.86%;采用中药提取机,混提法制备的复方健胃分散片中延胡索乙素的平均含量为2.459 mg/g,RSD=0.59%(n=6);单提法制备的复方健胃分散片中延胡索乙素的平均含量为1.954 mg/g,RSD=2.16%(n=6);结论:HPLC测定延胡索乙素具有较好的优势,操作简单且重复性好,为延胡索质量标准的制定提供了科学依据。建立的HPLC方法灵敏度高,操作简便,结果准确,重复性好,可用于中药复方健胃分散片中延胡索乙素含量测定,并且中药提取机混提法所制备的中药复方分散片中延胡索乙素含量较高,效果较好。

Objective： To determine and analyze Tetrahydropalmatine content in Chinese medicine Compound stomach dispersible tablets by high performance liquid chromatography（HPLC）. Methods： The HPLC method was used. The chromatographic column was Agilent TC-C18, which was 250 mm×4.6 mm, 5.0μm, mobile phase： 0.1% acetonitrile and acetic acid solution with pH 6.4. The elution gradient of pH was 6.4 with Triethylamine solution. The detection wavelength was 282 nm and the flow rate was1.0 ml/min. Using the Tetrahydropalmatine content as an indicator, an uniform design method was used. Results： The regression equation of Tetrahydropalmatine in the Chinese medicine Compound stomach dispersible tablets was Y=15.99078 X-7.09624（r=0.9997）. The Tetrahydropalmatine content showed a good linearity with the peak area in the content range of 0.1-1.0μg/mL. The average recovery rate was 99.86%. The average content of Tetrahydropalmatine in the Compound Stomach dispersible tablets prepared by the compound extraction method was 2.459 mg/g, and the RSD was 0.59%（n=6）, while the average content of Tetrahydropalmatine in Compound Stomach dispersible tablets prepared by the single extraction method was 1.954 mg/g, and the RSD=2.16%（n=6）. Conclusions： HPLC in the determination of Tetrahydropalmatine content has greater advantages, including simple operation and good repeatability, which provides a scientific basis for the development of its quality standards. The established HPLC method has the characteristics of high sensitivity, simple operation, accurate results and good repeatability. It can be used for the determination of Tetrahydropalmatine content in traditional Chinese medicine Compound stomach dispersible tablets prepared by using Chinese medicine extracting machine and through the compound extraction method with good effects.