ELSD-HPLC法测定健腰密骨片中黄芪甲苷的含量  

Determination of Astragaloside in JianYao MiGu Tablets by ELSD-HPLC

作　　者：许雯雯 李筱婧 詹常森 XU Wen-wen;LI Xiao-jing;ZHAN Chang-sen(Shanghai Hutchison Pharmaceuticals/Shanghai Engineering Research Center for Innovation of Solid Preparation of TCM,Shanghai 201401,China)

机构地区：[1]上海和黄药业有限公司/上海中药固体制剂创新工程技术研究中心,上海201401

出　　处：《海峡药学》2022年第9期35-38,共4页Strait Pharmaceutical Journal

基　　金：2019年国家科技部重大新药创制项目(2019ZX09201004-003-031)。

摘　　要：目的建立健腰密骨片中黄芪甲苷的ELSD-HPLC含量测定方法,为评价健腰密骨片质量提供依据。方法采用ELSD-HPLC法,用沃特世XBridge C_(18)色谱柱(250 mm×4.6 mm,5μm),乙腈和水作为流动相,进行梯度洗脱,流速为1.0 mL·min^(-1),柱温为25℃,测定健腰密骨片中黄芪甲苷含量。结果黄芪甲苷进样量在0.4966~7.946μg范围内,其对数与峰面积对数呈良好线性关系(r=0.9990);平均加样回收率以及RSD分别为101.86%和3.97%。结论该方法准确、简便,重复性好,为健腰密骨片质量评价提供可靠的分析方法。OBJECTIVE To establish an ELSD-HPLC method for the determination of astragaloside in JianYao MiGu tablets,in order to provide a basis for evaluating the quality of JianYao MiGu tablets.METHODS The ELSD-HPLC method was used to determine the coutent of astragaloside in JianYao MiGu tablets.Waters XBridge C_(18) column(250 mm×4.6 mm,5μm)was used as the chromatographic column,acetonitrile-water was used as the mobile phase for gradient elution,the flow rate was 1.0 mL·min^(-1) and the column temperature was 25℃.RESULTS Astragaloside showed a good linearity between the logarithm of peak area and the logarithm of injection quantity in the range of 0.4966-7.946μg(r=0.9990).The average recovery rate of astragaloside was 101.86%,and the RSD was 3.97%.CONCLUSION The method is accurate,simple,and reproducible.It provides a reliable analytical method for evaluating the quality of JianYao MiGu tablets.

关 键 词：健腰密骨片 黄芪甲苷 ELSD-HPLC法 含量测定 

分 类 号：R927[医药卫生—药学]