HPLC法测定肠炎宁颗粒中芦丁、迷迭香酸的含量  

Determination of Rutin and Rosmarinic Acid in ChangYanNing GranuLes by HPLC

作　　者：何凤 严建良 吴孔松 谢建军 HE Feng;YAN Jian-liang;WU Kong-song;XIE Jian-jun(Jiangxi CONBA Tianshikang Pharmaceutical Co.,Ltd.,Yingtan 335000,China)

机构地区：[1]江西康恩贝天施康药业有限公司,江西鹰潭335000

出　　处：《海峡药学》2022年第3期86-89,共4页Strait Pharmaceutical Journal

摘　　要：目的 建立测定肠炎宁颗粒中芦丁、迷迭香酸含量的高效液相色谱法。方法 采用经验证的HPLC对11批次肠炎宁颗粒中芦丁、迷迭香酸进行含量测定。检测条件为AgilentC_(18)柱(250 mm×4.6 mm,5μm);流动相为乙腈-0.05%磷酸溶液(18∶82);流速1.0 mL·min^(-1);检测波长350 nm。结果 芦丁在1.1973~38.3123μg·mL^(-1)(r=1.000)范围内与峰面积呈良好线性关系,平均回收率为100.46%,RSD为0.61%(n=6);迷迭香酸在2.0074~64.2369μg·mL^(-1)(r=0.9995)范围内与峰面积呈良好线性关系,平均回收率为101.73%,RSD为0.76%(n=6)。结论 所建立的方法简便可行,结果准确可靠,重复性好,为提升产品质量控制指标的选择及其限度的确定提供了参考,同时为更好地控制产品质量提供了实验依据。OBJECTIVE To develop a method for simultaneous determination of rutin and rosmarinic acid in ChangYanNing Granules with High-performance Liquid Chromatography(HPLC).METHODS Determination of rutin and rosmarinic acid in ChangYanNing Granules with 11 batchs by HPLC which was verified.The separation was performed on an Agilent Zorbax Eclipse XDB-C_(18) Column(250 mm×4.6 mm,5 μm)with a mobile phase of acetonitrile-0.05%phosphoric acid(18∶82).The flow rate was 1.0 mL·min^(-1).The detection wavelength was 350 nm.RESULTS The calibration cure of rutin was performed over the range of 1.1973-38.3123 μg·mL^(-1)(r=1.000),and the average recovery was 100.46%(n=6).The calibration cure of rosmarinic acid was performed over the range of 2.0074-64.2369 μg·mL^(-1)(r=0.9995),and the average recovery was101.73%(n=6).CONCLUSION The method is accurate and repeatable which provides a reference for improving the selection of quality control indexes and the determination of their limits,at the same time,it provides the experimental basis for better control of product quality.

关 键 词：肠炎宁颗粒 HPLC 芦丁 迷迭香酸 含量测定 

分 类 号：R927[医药卫生—药学]