HPLC法测定皮炎消冲剂中梓醇的含量

Determination the content of catalpol in Piyanxiao granule by HPLC

目的 建立简便可行的皮炎消冲剂中梓醇的含量测定方法,为产品质量监控提供参考。方法采用Agilent 1200高效液相色谱仪,确定梓醇标准品最佳分析参数,建立峰面积y（mAU·min）与梓醇含量x（mg/mL）之间的关系式,并利用加标回收率实验来证实此分析方法的可靠性和精密度,然后再对市售皮炎消冲剂产品进行分析。结果 当选用Agilent色谱柱,以水-乙腈-甲醇（95∶2∶3）混合物作为流动相,检测波长选定212nm,流动相流速为0.8mL/min时,HPLC法测定梓醇在0.008-0.8mg/mL范围内,峰面积y（mAU·min）与梓醇含量x（mg/mL）之间呈现良好的线性关系,线性回归方程可以表示为y=7 528x-51.76,其线性相关系数R2=0.999。此方法加标回收率实验结果显示,6个平行样品平均回收率为100.43%,RSD为1.08%。将此方法用于皮炎消冲剂中梓醇的含量测定,结果表明,梓醇含量为0.543 6-0.561 2mg/g,RSD在0.97%-1.07%之间。结论 本方法简便、高效、重现性好,可以用于皮炎消冲剂生产过程中对梓醇含量的监控,以确保产品质量的稳定性。

Objective--To establish a simple and feasible method for determination the content of catal- pol in Piyanxiao Granules, and provide reference for quality control. Methods--Agilent 1200 high performance liquid chromatography （HPLC） was used to determine the optimal analysis parameters of reference catalpol, establish relationships between the peak area y （mAU ·min） and catalpol concen- tration x （mg/mL）, confirm the reliability and precision of the analysis method with the recovery of standard addtion, and then analyze the granules products commercially available. Result--There exists a good linear relationship between peak area y （mAU · min） and catalpol concentration x （mg/mL） when the catalpol, which was determined by HPLC using Agilent chromatographic column with water -acetonitrile-methanol （95 ： 2 ： 3） mixture as the mobile phase, 212 nm as detection wavelength, 0.8 mL/min as flow rate, was in the range of 0.008 - 0.8 mg/mL. The linear regression equation can be expressed as y=7 528x-51.76, and the linear correlation coefficient was R^2= 0. 999. The results of standard addition recovery showed the average recovery of six parallel samples was 100.43 % and RSD was 1.08%. When the method was applied to the determination of catalpol in Piyanxiao granules, the results showed that the content of catalpol was between 0. 543 6 - 0. 561 2 mg/g, RSD between 0. 97- -1.07%. Conclusion--The method boasts simplicity, efficiency and reproducibility, so it can be used in the production process of Piyanxiao granules to monitor the content of catalpol for the purpose of ensuring the stability of product quality.