清炎颗粒中没食子酸定性定量方法的研究

Qualitative and quantitative analysis of the active substance of gallic acid in qingyan granules

目的 建立测定清炎颗粒中没食子酸定性与定量的方法。方法 用薄层层析法对清炎颗粒有效成分没食子酸进行定性分析;采用反相高效液相色谱法建立了外标法测定没食子酸的定量分析法。Waters公司的Breeze系列高效液相色谱仪,Hypersil BDS C18色谱柱(5μm,1.6 mm×100 mm),流动相:乙腈-0.05％(v v)磷酸溶液(5:95.v v),流速:1.0 mL·min-1.检测波长:272 nm,柱温:40℃,进样量20μL,灵敏度:0.02 AUFS。结果 没食子酸进样量在7.2～57.6μg·mL-1与峰面积积分值呈良好的线性关系(r=0.99994),平均回收率为100.6％,RSD=1.0％(n=5)。结论 本方法灵敏、简便、重现性好,可有效地控制制剂质量。

OBJECTIVE To establish quality control methods for qingyan granules by qualitatively and quantitatively determining the active substance in gallic acid. METHODS We determined the nature of gallic acid by thin layer chromatography (TLC). The content of gallic acid in qingyan granules was measured by RP-HPLC. Waters Breeze System was used with a Hypersil BDS C18 column (5μm. 1.6 mm × 100 mm). The mobile phase was composed of acetonitrile and 0. 05% (v v) H3 PO1 water solution (5 : 95, v/v); flow rate: 1.0 mL· min-1; wavelength of UV detector: 272 nm; column temperature: 40 C . RESULTS The calibration curve of gallic acid was linear over the range of 7. 2-57. 6μg· mL-1 (r=0. 99994). The average recovery rale was 100. 6%, RSD= 1.0% (n=5). CONCLUSIONS This method is simple, sensitive, and reliable, and it is effective for quality control.