HPLC法测定滑膜炎制剂中毛蕊异黄酮葡萄糖苷的含量

Determination of Calycosin7-O-β-D-Glucopyranoside for Preparation of Huamoyan by HPLC

目的:建立滑膜炎片、滑膜炎颗粒中毛蕊异黄酮葡萄糖苷含量的测定方法。方法:对国内5个企业生产的45批次样品进行检测,采用色谱柱Agilent TC-C 18(2)(4.6 mm×250 mm,5μm);流动相为乙腈-0.1%磷酸溶液(15∶85)梯度洗脱,流量1.0 mL·min^-1;检测波长260 nm;柱温35℃。结果:毛蕊异黄酮葡萄糖苷回归方程为:y=33733733.0734x-8054.2310,相关系数r 2=0.9997(n=6)。毛蕊异黄酮葡萄糖苷的线性范围均在1.029~20.574μg·mL^-1。结论:本方法操作简便、准确、专属性强、稳定,可用于滑膜炎片/颗粒中毛蕊异黄酮葡萄糖苷的含量测定。

Objective:To establish a method for determination of Calycosin7-O-β-D-Glucopyranoside in Huamoyan tablets and granules.Methods:Test 45 batches of samples produced by 5 domestic companies,The HPLC was performed on theAgilent TC-C 18(2)(4.6 mm×250 mm,5μm)with the mobile phase of acetonitrile-0.1%phosphoric acid solution bygradient elution,the flow rate was 1.0 mL·min-1;the detection wavelength was 260 nm.The column temperature was 35℃.Results:Verbasic isoflavone glucoside regression equation is:y=33733733.0734x-8054.2310,Correlation coefficient r 2=0.9997(n=6).The concentrations of Calycosin7-O-β-D-Glucopyranoside were within the range of 1.029-20.574μg·mL^-1.Conclusion:The method is simple,accurate,specific,and stable,and can be used for the determination the content of Calycosin7-O-β-D-Glucopyranoside in tablets/granules.