HPLC法测定双花百合片中绿原酸含量.docVIP

HPLC法测定双花百合片中绿原酸含量[摘要] 目的：建立双花百合片中绿原酸的含量测定方法。方法：采用HPLC法，色谱柱为Eclispse XDB C18（4.6 mm×250 mm，5 μm）色谱柱，流动相为0.4%磷酸溶液-乙腈（85∶15），柱温为25℃，流速为0.8 ml/min，检测波长为327 nm。结果：绿原酸在0.10~5.00 μg范围内呈良好的线性关系（r=0.999 7），平均回收率为99.60%，RSD=1.56%（n=6）；测得3个批次双花百合片样品中绿原酸含量分别为0.08、0.10、0.09 mg/片。结论：该方法操作简单，灵敏度高，重现性好，测定结果可靠，可用于双花百合片中绿原酸含量的测定。 [关键词] 双花百合片；绿原酸；含量测定；高效液相色谱法 [中图分类号] R927.2 [文献标识码] C[文章编号] 1674-4721（2011）07（b）-038-02 Determination of chlorogenic acid in Shuanghua Baihe tablet by HPLC SHI Guoju Department of Pharmacy, People’s Hospital in Shangcai County, Henan Province, Shangcai 463800, China [Abstract] Objective: To establish the method for determination of the chlorogenic acid in Shuanghua Baihe tablet. Methods: Eclispse XDB C18 (4.6 mm×250 mm, 5 μm) was used as stationary phase, 0.4% phosphoric acid-acetonitrile (15:85) was used as mobile phase, at the rate of 0.8 ml/min, the detective wavelength was 327 nm. Results: The linear range of chlorogenic acid was between 0.10 and 5.00 μg (r=0.999 7), and the average recoveries was 99.60%, RSD was 1.56% (n=6). Each tablet contains chlorogenic acid 0.08, 0.10, 0.09 mg in 3 batches of sample. Conclusion: The method is simple, high sensitivity, good reproducibility and reliable in results, and can be used as the determination of the chlorogenic acid in Shuanghua baihe tablet. [Key words] Shuanghua Baihe tablet; Chlorogenic acid; Determination of contents; HPLC 双花百合片是由黄连、苦地丁、生地黄、板蓝根、紫草、金银花、淡竹叶、蛇胆、百合、细辛等药味组成的中成药制剂，具有清热泻火，解毒凉血之功效，可用于复发性口腔溃疡、口腔白斑、口腔扁平苔藓、白塞综合征等病症[1]，绿原酸是该方药中的重要抗菌活性成分。为控制双花百合片的内在质量，本研究特采用HPLC法测定该制剂中绿原酸的含量，为双花百合片的质量控制提供了参考性资料。现将资料报道如下： 1 仪器与试药 1.1 仪器 Agilent1200型高效液相色谱仪：四元梯度泵，柱温箱，二级管阵列检测器，Chemistation色谱工作软件；KQ-700DV型数控超声波清洗器（昆山市超声波仪器有限公司）；FA1004型电子分析天平（上海良平仪器仪表有限公司）。 1.2 试药 绿原酸对照品（中国药品生物制品检定所，批号110753-200811，供含量测定用）；乙腈、甲醇为色谱纯，水为重蒸馏水，其他试剂均为分析纯；双花百合片（自制，批号100318、100412、100509）。 2 方法与结果 2.1 色谱条件 色谱柱：Eclispse XDB C18（4.6 mm×250 mm，5 μm）；流动相：0.4%磷酸溶液-乙腈（85∶15）；检测波长：327 nm；流速：0.8 ml/min；柱温